Welcome to EAS-e-Docs, a free service offering selected documents we believe can help companies comply with FDA's laws and regulations.
How EAS-e-Docs Work
Just select the document you need from the list, enter your contact information, and we will send you an e-mail message with a link to the document.
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, tel: (301) 294-1771.
The latest additions to the free EAS-e-Docs service include:
Drugs
Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application
This guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application (IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA.
Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems
This draft guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development—as well as during manufacturing and product lifecycle management—to ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The draft guidance is applicable to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (sNDAs) for TDDS, TMDS, and topical patch products.
Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products
The guidance provides recommendations on the design of label comprehension studies that can be used to assess the extent to which consumers understand the information conveyed by proposed nonprescription drug product labeling. This guidance finalizes the draft guidance published on May 1, 2009.
Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use--Small Entity Compliance Guide
The guidance describes the organ-specific labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act.
Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment
The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA’s thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of the changes in the definitions of ABSSSI and the recommendations for clinical drug development.
Foods
Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation
The draft guidance, when finalized, will provide guidance to egg producers on how to comply with certain provisions contained in FDA’s final rule ‘‘Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation’’ (the final rule), including how to implement Salmonella Enteritidis (SE) prevention measures, how to sample for SE, and how tomaintain records documenting compliance with the final rule.
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
Section 4205 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) establishes requirements for nutrition labeling of standard menu items for chain retail food establishments and chain vending machine operators. FDA is issuing this guidance to clarify section 4205’s effect on State and local menu and vending machine labeling laws, and to ensure that industry and State and local government understand the immediate effects of the law.
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
Section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act) requires certain chain restaurants and similar retail food establishments with 20 or more locations (hereinafter ‘‘chain retail food establishments’’) to provide calorie information, and other nutrition information, for standard menu items, food on display, and self-service food. Section 4205 also requires vending machine operators who own or operate 20 or more machines (hereinafter ‘‘chain vending machine operators’’) to disclose calories for articles of food. Restaurants and similar retail food establishments with fewer than 20 locations and vending machine operators with fewer than 20 machines may elect to be subject to these Federal requirements by registering every other year with the FDA.
GAO Report
New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials
This report covers a review FDA’s use of evidence from non-inferiority trials to establish a drug’s effectiveness and support approval. The report (1) identify the type and status of drug applications submitted for FDA review that included evidence from non-inferiority trials; (2) examine the characteristics of non-inferiority trials FDA considered in making approval decisions; and (3) describe FDA’s guidance for establishing a drug’s effectiveness on the basis of non-inferiority trials.
Medical Devices
Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices
This guidance document was developed to assist industry in designing evaluation strategies for, and reporting the results of, animal studies involving cardiovascular devices, including intra-cardiac devices and devices used in the coronary and peripheral vasculature.
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
This two-volume set of documents entitled ‘‘Center for Devices and Radiological Health Preliminary Internal Evaluations,’’ which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled ‘‘510(k) Working Group Preliminary Report and Recommendations.’’ Volume II is entitled ‘‘Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.’’ The recommendations contained in these reports are preliminary. FDA has not made any decisions on specific changes to pursue. FDA is soliciting public input on the recommendations discussed in these reports, including the feasibility of implementation and potential alternatives. Once its assessment of public input and other necessary reviews are completed, FDA will announce which improvements it will implement, as well as projected timelines for implementation.
Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays
This draft guidance document discusses information to be included in premarket notifications for lamotrigine or zonisamide assays. This draft guidance is not final nor is it in effect at this time.
Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling
This guidance document is an addendum to a special control guidance that supports the classification of the Contact Lens Care Products as class II (special controls). This draft guidance will be issued in conjunction with a Federal Register notice announcing the recommendations for labeling of contact lens care products.
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)
This guidance identifies the key features of non‐clinical and clinical investigational plans used to support investigational device exemptions (IDEs), premarket approval applications (PMAs), and some premarket notifications (510(k)s) for devices used in the treatment of BPH. Some recommendations in this document may not apply to a particular device, and additional recommendations may be appropriate for novel device types or technologies.
Tobacco
Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers
This guidance document is intended to describe FDA’s current policies with respect to civil money penalties and notobacco- sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products, including the FD&C Act requirement that tobacco products may not be sold or distributed in violation of FDA’s ‘‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.’’ When this guidance document is final, several provisions in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders will become effective.
Veterinary
Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed
The draft CPG, when finalized, is intended to provide guidance for FDA staff on regulatory policy relating to animal feed or feed ingredients that come in direct contact with humans, such as pet food and pet treats, contaminated with Salmonella and also on regulatory policy relating to animal feed or feed ingredients contaminated with a Salmonella serotype that is pathogenic to the target animal for the animal feed.
Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information
This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.
Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R)
The guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers of products derived from treated food producing animals. It is intended to assist in developing new animal drug applications (referred to as marketing applications in this guidance) submitted to the European Union, Japan, and the
United States.
Currently available EAS-e-Docs:
| EAS-e-Doc Number | Title of Document |
|---|---|
| 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. |
| 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 |
| 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 |
| GAO | |
| GAO001-10 | New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials |
| 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) |
| 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 |
| 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) |
