Welcome to EAS-e-Docs, a free service offering selected documents we believe can help companies comply with FDA's laws and regulations.
In addition to this free service, EAS can locate other hard-to-find FDA documents on your behalf, for a document retrieval fee. Documents retrieved through a Freedom of Information Act (FOIA) request may incur FDA copy and research charges (at cost). For details, contact Chris Celeste, Director of Regulatory Information and Submissions, e-mail: cceleste@easconsultinggroup.com, telephone: (301) 294-1771.
Complete EAS-e-Doc Archive:
| EAS-e-Doc Number | Title of Document |
|---|---|
| Biologics | |
| B001-10 | Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information |
| B002-10 | Guidance for Industry: Cellular Therapy for Cardiac Disease |
| B003-11 | Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability, and Reporting Certain Changes to an Approved Application |
| B004-11 | Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion |
| B005-11 | Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion |
| B006-11 | Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products |
| B007-11 | Guidance for Industry: "Computer Crossmatch" (Computerized Analysis of the Compatibility Between the Donor's Cell Type and the Recipient's Serum or Plasma Type) |
| B008-11 | Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral Small Entity Compliance Guide |
| B009-11 | Draft Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma |
| B010-11 | Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications |
| B011-11 | Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications |
| B012-11 | Guidance for Industry: Availability of FDA's eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments |
| B013-11 | Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components |
| B014-11 | Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines |
| B015-11 | Draft Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive |
| B016-12 | Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products |
| Compliance Policy Guides | |
| CPG001-11 | Compliance Policy Guide Sec. 527.300 Dairy Products--Microbial Contaminants and Alkaline Phosphatase Activity |
| CPG002-11 | Draft Compliance Policy Guide Sec. 510.800 Beverages--Serving Size Labeling |
| CPG003-11 | Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date |
| CPG004-11 | Compliance Program Guidance Manual - Chapter 42 - Blood and Blood Products - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 |
| CPG005-11 | Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations |
| CPG006-11 | Compliance Policy Guide Sec. 335.700, Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure |
| Cosmetics | |
| C001-10 | Compliance Program Guidance Manual 7329.001 - Cosmetics Program; Import and Domestic. |
| Dietary Supplements | |
| DS001-10 | Compliance Program: Dietary Supplements -Imports And Domestic (7321.008) |
| DS002-10 | GAO's "Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice" |
| DS003-10 | Hatch Takes Issue with GAO's Report on Dietary Supplements |
| DS004-10 | Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. |
| DS005-11 | Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements |
| DS006-11 | Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues |
| Drugs | |
| D001-10 | Guidance for Industry: CMC Postapproval Manufacturing Changes Reportable in Annual Reports. |
| D002-10 | ICH; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter. |
| D003-10 | ICH; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions; Annex 14 on Bacterial Endotoxins Test General Chapter. |
| D004-10 | ICH; Draft Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents. |
| D005-10 | Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application |
| D006-10 | Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems |
| D007-10 | Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products |
| D008-10 | Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use--Small Entity Compliance Guide |
| D009-10 | Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment |
| D010-10 | International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter |
| D011-10 | International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 11 on Capillary Electrophoresis General Chapter |
| D012-10 | Draft Guidance for Industry: Bar Code Label Requirements--Questions and Answers (Question 12 Update) |
| D013-10 | Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials |
| D014-10 | Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment |
| D015-10 | Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies |
| D016-10 | Final Rule - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans |
| D017-10 | Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application |
| D018-10 | MAPP 4151.1R Scientific / Regulatory Dispute Resolution for Individuals Within a Management Chain |
| D019-10 | MAPP 4151.2R Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director |
| D020-10 | MAPP 4151.8 Equal Voice: Discipline and Organizational Component Collaboration in Scientific and/or Regulatory Decisions |
| D021-10 | Draft Guidance for Industry on Qualification Process for Drug Development Tools |
| D022-10 | MAPP - 4180.4 NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide |
| D023-10 | Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information |
| D024-10 | Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment |
| D025-10 | Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products |
| D026-10 | Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval |
| D027-11 | Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination |
| D028-11 | ICH Q8 (Pharmaceutical Development, I, II) |
| D029-11 | The ICH Q9 (Quality Risk Management) |
| D030-11 | ICH Q10 Pharmaceutical Quality Systems |
| D031-11 | Pre-Approval Inspections Compliance Program |
| D032-11 | Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic |
| D033-11 | Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Opportunity to Affirm Outstanding Hearing Requests; Final Resolution of Dockets |
| D034-11 | Prescription Drug Products Containing Acetaminophen; Actions to Reduce Liver Injury From Unintentional Overdose |
| D035-11 | Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle |
| D036-11 | Guidance for Industry on Process Validation: General Principles and Practices |
| D037-11 | Draft Guidance on Positron Emission Tomography Drug Applications--Content and Format For New Drug Applications and Abbreviated New Drug Applications |
| D038-11 | Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph |
| D039-11 | Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets |
| D040-11 | Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies |
| D041-11 | FY 2010 PDUFA Performance Report - Commissioner's Report |
| D042-11 | Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies |
| D043-11 | Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products |
| D044-11 | Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims |
| D045-11 | Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products |
| D046-11 | Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework |
| D047-11 | Federal Register Notice: Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Final Resolution of Dockets |
| D048-11 | Federal Register Notice: Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and Offered for Relief of Symptoms of Cold, Cough, or Allergy; Enforcement Action Dates |
| D049-11 | Federal Register Notice: Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment |
| D050-11 | Federal Register Notice: Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use |
| D051-11 | Guidance for Industry on Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act |
| D052-11 | Guidance for Industry on Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act |
| D053-11 | Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent for Emergency Research |
| D054-11 | Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act |
| D055-11 | Guidance for Industry on How to Write a Request for Designation |
| D056-11 | Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products |
| D057-11 | Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications |
| D058-11 | Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators |
| D059-11 | ANDA Filing Checklist (CTD or eCTD Format) For Completeness and Acceptability of an Application |
| D060-11 | List of Center for Drug Evaluation and Research Key Officials |
| D061-11 | Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies |
| D062-11 | Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act |
| D063-11 | Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology |
| D064-11 | Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Rule |
| D065-11 | Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms |
| D066-11 | Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Final Rule |
| D067-11 | Sunscreen Drug Products for Over-the-Counter Human Use; Final Rule Correction |
| D068-11 | Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application |
| D069-11 | Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics |
| D070-11 | Draft Guidance for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues; and Draft Guidance for Industry and Food and Drug Administration Staff: Interpretation of the Term Chemical Action in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act |
| D071-11 | Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective; Small Entity Compliance Guide |
| D072-11 | International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7(R2) on Dissolution Test General Chapter |
| D073-11 | International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances |
| D074-11 | CDER Therapeutic Biologic Products |
| D075-11 | Federal Register Notice: Final Rule - Labeling for Bronchodilators to Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use |
| D076-11 | Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs |
| D077-11 | Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs |
| D078-11 | Guidance for Industry: Bar Code Label Requirements--Questions and Answers |
| D079-11 | International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions |
| D080-11 | Guidance for Industry: Residual Drug in Transdermal and Related Drug Delivery Systems |
| D081-11 | Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints |
| D082-11 | International Conference on Harmonisation; Guidance on E2F Development Safety Update Report |
| D083-11 | Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention |
| D084-11 | Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring |
| D085-11 | Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation |
| D086-11 | Guidance on Positron Emission Tomography Drug Applications--Content and Format for New Drug Applications and Abbreviated New Drug Applications |
| D087-11 | Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products |
| D088-11 | Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs |
| D089-11 | Guidance for Industry on Reproductive and Developmental Toxicities--Integrating Study Results to Assess Concerns |
| D090-11 | Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products |
| D091-11 | Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs |
| D092-11 | Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products |
| D093-11 | FDA Conducts Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case Information - September 2011 |
| D094-11 | Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format |
| D095-11 | Guidance for Industry on Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting |
| D096-11 | International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility |
| D097-11 | Draft Documents to Support Submission of an Electronic Common Technical Document |
| D098-11 | Formatting of Bioequivalence Summary Tables |
| D099-11 | Question-based Review (QbR) for Sterility Assurance of Terminally Sterilized Products: Quality Overall Summary Outline |
| D100-11 | Question-based Review (QbR) for Sterility Assurance of Terminally Sterilized Products: Frequently Asked Questions |
| D101-11 | Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals |
| D102-11 | Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies |
| D103-11 | Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals |
| D104-11 | Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals |
| D105-12 | Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals |
| D106-12 | Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices |
| D107-12 | Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies |
| D108-12 | E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and Message Specification |
| Foods | |
| F001-10 | Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety; Draft Guidance. |
| F002-10 | A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry. |
| F003-10 | Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed. |
| F004-10 | Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation |
| F005-10 | Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws |
| F006-10 | Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010 |
| F007-10 | Draft Guidance for Industry: Acidified Foods |
| F008-10 | Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of the Term "Lead Free" in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative Ceramicware |
| F009-11 | Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease |
| F010-11 | Uniform Compliance Date for Food Labeling Regulations |
| F011-11 | FDA Foods Program - The Reportable Food Registry: A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration - First Annual Report: September 8, 2009 - September 7, 2010 |
| F012-11 | DFI Field Bulletin #30 - Food Program Area Instructions for Environmental Sampling |
| F013-11 | Irradiation in the Production, Processing, and Handling of Food Final Rule |
| F014-11 | Guidance for Industry on Fish and Fishery Products Hazards and Controls, Fourth Edition |
| F015-11 | Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption |
| F016-11 | Information Required in Prior Notice of Imported Food |
| F017-11 | Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation |
| F018-11 | Federal Register Notice: Final Rule -Food Additives Permitted for Direct Addition to Food for Human Consumption; Hydroxypropyl Cellulose |
| F019-11 | Federal Register Notice – Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period |
| F020-11 | Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten |
| F021-11 | External Peer Review of the FDA/CFSAN Draft Health Hazard Assessment for Gluten in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten |
| F022-11 | Federal Register Notice: Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012 |
| F023-11 | Federal Register Notice: Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012; Correction |
| F024-11 | Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient |
| F025-11 | Guidance for Industry Implementation of the Fee Provisions of the FDA Food Safety Modernization Act |
| F026-11 | Federal Register Notice - Beverages: Bottled Water Quality Standard; Establishing an Allowable Level for di(2-ethylhexyl)phthalate |
| F027-11 | Guidance for Industry on Evaluating the Safety of Flood-affected Food Crops for Human Consumption |
| F028-11 | Guidance for Industry on What You Need to Know About Administrative Detention of Foods |
| F029-11 | Federal Register Notice - Memorandum of Understanding Between the Food and Drug Administration and the U.S. Department of Agriculture’s Agricultural and Marketing Service, Farm Service Agency, and Food Nutrition Service |
| F030-12 | Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation |
| F031-12 | The Federal Food Safety Working Group Progress Report |
| GAO | |
| GAO001-10 | New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials |
| GAO002-10 | Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-term Planning Is Needed. GAO-10-960 |
| GAO003-10 | Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed. GAO-10-961 |
| GAO004-10 | Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working With External Entities Were Recently Added, GAO-11-95 |
| GAO005-11 | Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims |
| GAO006-11 | Prescription Drugs: Trends in Usual and Customary Prices for Commonly Used Drugs |
| GAO007-11 | Federal Food Safety Oversight: Food Safety Working Group Is a Positive First Step but Government wide Planning Is Needed to Address Fragmentation |
| GAO008-11 | Medical Devices: FDA's Premarket Review and Postmarket Safety Efforts |
| GAO009-11 | Pediatric Research: Products Studied under Two Related Laws, but Improved Tracking Needed by FDA |
| GAO010-11 | Antibiotic Resistance: Data Gaps Will Remain Despite HHS Taking Steps to Improve Monitoring |
| GAO011-11 | Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated into Future Planning |
| GAO012-11 | Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure |
| GAO013-11 | Medical Devices: FDA Should Enhance Its Oversight of Recalls |
| GAO014-11 | USDA Systems Modernization: Management and Oversight Improvements Are Needed |
| GAO015-11 | President's Emergency Plan for AIDS Relief: Program Planning and Reporting |
| GAO016-11 | Antibiotic Resistance: Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals |
| GAO017-11 | Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain |
| GAO018-11 | Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement |
| GAO019-11 | Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters |
| GAO020-11 | Food and Drug Administration: Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health |
| GAO021-12 | Drug Shortages: FDA's Ability to Respond Should Be Strengthened |
| GAO022-12 | Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting |
| General | |
| G001-11 | Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings |
| G002-11 | Good Laboratory Practice for Nonclinical Laboratory Studies |
| G003-11 | HHS - Food and Drug Administration - FY2011 Online Performance Appendix |
| G004-11 | HHS Office of Inspector General - FDA's Approval Status of Drugs Paid for by Medicaid |
| G005-11 | HHS Office of Inspector General - Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trails |
| G006-11 | HHS Office of Inspector General - FDA Inspections of Domestic Food Facilities |
| G007-11 | FDA Special Report - Pathway to Global Product Safety and Quality |
| G008-11 | FDA - TRANSPARENCY INITIATIVE: DRAFT PROPOSALS FOR PUBLIC COMMENT TO INCREASE TRANSPARENCY BY PROMOTING GREATER ACCESS TO THE AGENCY’S COMPLIANCE AND ENFORCEMENT DATA |
| G009-12 | Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency |
| G010-12 | Federal Register Notice: Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, Proposed Rule |
| MaPPs | |
| MAPP001-11 | MaPP 4200.4 - Office of Generic Drugs (OGD) Consultation with the Controlled Substance Staff (CSS) on Subject Abbreviated New Drug Application (ANDA) Submissions |
| MAPP002-11 | MaPP 5016.1 - Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review |
| MAPP003-11 | MaPP6700.9 - FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System |
| MAPP004-11 | MaPP 6004.1, Rev. 1 - Office of Surveillance and Epidemiology: Responding to Requests For Waivers of Postmarketing Safety Reporting Requirements under 21 CFR - 314.80 (NDAs), 314.98 (ANDAs), and 600.80 (BLAs) |
| MAPP005-11 | MAPP 6004-1, Rev.1 Responding to Requests for Waivers of Postmarketing Safety Reporting Requirements under 21 CFR - 314.80 (NDAs), 314.98 (ANDAs) and 600.80 (BLAs) |
| MAPP006-11 | MAPP 7400.1 Rev. 2 - Management of the CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Group |
| MAPP007-11 | MaPP 7400.1 Rev. 2 - Management of the CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups |
| MAPP008-11 | MaPP 4400.1 – Guide to the Orientation Program in the Center for Drug Evaluation and Research |
| MAPP009-11 | MaPP 4400.2 – Accreditation – Continuing Education |
| MAPP010-11 | MaPP 4400.3 – CDER Federated Training Model |
| MAPP011-11 | MAPP 5015.5, Rev. 1, CMC Reviews of Type III DMFs for Packaging Materials |
| MAPP012-11 | MAPP 4000.1 Rev.3 |
| MAPP013-11 | MaPP 7600.8 – CDER Informatics Governance Process |
| MAPP014-11 | MaPP 4800.1– Procedures for the Office of Counter-Terrorism and Emergency Coordination Counter –Terrorism Seminar (CT Seminar) |
| MAPP015-12 | MAPP 4800.1 - Procedures for the Office of Counter-Terrorism and Emergency Coordination Counter- Terrorism Seminar (CT Seminar) |
| MAPP016-12 | MAPP 4658.2 - Time Reporting System |
| MAPP017-12 | MAPP 6030.6 – INDs: Processing Treatment INDs and Treatment Protocols |
| MAPP018-12 | MAPP 6002.4 - Government-Issued Nonaccountable Personal Property |
| MAPP019-12 | MAPP 4121.2 Tracking of Significant Safety issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issues |
| Medical Devices | |
| MD001-10 | Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions. |
| MD002-10 | Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. |
| MD003-10 | Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices |
| MD004-10 | 1] Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations |
| MD005-10 | 2] Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations |
| MD006-10 | Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays |
| MD007-10 | Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling |
| MD008-10 | Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) |
| MD009-10 | Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers |
| MD010-10 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters |
| MD011-10 | Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori |
| MD012-10 | Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Herpes Simplex Virus Types 1 and 2 Serological Assays |
| MD013-10 | Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling |
| MD014-10 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System |
| MD015-10 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin |
| MD016-10 | Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) |
| MD017-10 | Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 |
| MD018-10 | Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile |
| MD019-10 | Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling |
| MD020-10 | Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus. |
| MD021-10 | Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi |
| MD022-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use Powder |
| MD023-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use |
| MD024-11 | CDRH Letter to Denture Adhesive Manufacturers regarding Zinc |
| MD025-11 | Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence |
| MD026-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System |
| MD027-11 | CDRH Letter to Industry about Import Entry Review Process |
| MD028-11 | Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket Approval Supplements and 75-Day Humanitarian Device Exemption Supplements for Manufacturing Method or Process Changes |
| MD029-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use |
| MD030-11 | Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic - Final Rule |
| MD031-11 | Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge - Final Rule |
| MD032-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities |
| MD033-11 | Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities |
| MD034-11 | Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling |
| MD035-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection |
| MD036-11 | Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection |
| MD037-11 | Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions |
| MD038-11 | Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing |
| MD039-11 | Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment |
| MD040-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices |
| MD041-11 | Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low Glucose Suspend Device Systems |
| MD042-11 | Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design |
| MD043-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices |
| MD044-11 | Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices |
| MD045-11 | Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses |
| MD046-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use |
| MD047-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes |
| MD048-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications |
| MD049-11 | Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems |
| MD050-11 | Draft Guidance for Industry and Food and Drug Administration Staff; 510 (k) Device Modifications: Deciding When to Submit a 510 (k) for a Change to an Existing Device |
| MD051-11 | Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2012 Medical Device User Fee Small Business Qualification and Certification |
| MD052-11 | Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays |
| MD053-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review |
| MD054-11 | Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices |
| MD055-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies |
| MD056-11 | Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation) |
| MD057-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator |
| MD058-11 | Medical Device Pre-Market Programs: An Overview of FDA Actions |
| MD059-11 | Accomplishments: CDRH Plan of Action for 510(k) and Science |
| MD060-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection |
| MD061-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies |
| MD062-11 | Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations |
| MD063-11 | SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions |
| MD064-11 | Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses |
| MD065-11 | Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems |
| MD066-12 | Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies |
| MD067-12 | Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices |
| MD068-12 | Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] |
| MD069-12 | Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes |
| MD070-12 | Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes |
| MD071-12 | Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations |
| Tobacco | |
| T001-10 | Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. |
| T002-10 | Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs. |
| T003-10 | Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers |
| T004-11 | Tobacco Products, Exemptions From Substantial Equivalence Requirements |
| T005-11 | Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products |
| T006-11 | Guidance for Industry and Food and Drug Administration Staff; "'Harmful and Potentially Harmful Constituents' in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act" |
| T007-11 | Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers |
| T008-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 |
| T009-11 | Required Warnings for Cigarette Packages and Advertisements; Final Rule |
| T010-11 | Tobacco Products, Exemptions From Substantial Equivalence Requirements; Final Rule |
| T011-11 | Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products |
| T012-11 | Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions |
| T013-11 | Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products |
| T014-11 | Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements |
| T015-11 | Federal Register Notice: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents – Proposed Rule |
| Veterinary | |
| V001-10 | Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed |
| V002-10 | Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information |
| V003-10 | Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R) |
| V004-10 | Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species |
| V005-10 | Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor Uses or Minor Species |
| V006-10 | Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed |
| V007-11 | Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers |
| V008-11 | The National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan 2011 - 2015 |
| V009-11 | Draft Guidance for Industry on "Target Animal Safety and Effectiveness Protocol Development and Submission" |
| V010-11 | Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use |
| V011-11 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised Guidance for Industry on "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI" (VICH GL-36(R)) |
| V012-11 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues |
| V013-11 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods |
| V014-11 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals |
| V015-11 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies |
| V016-11 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data |
| V017-11 | Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and Submission |
| V018-11 | Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision), VICH GL18 |
| V019-11 | Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals |
