EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest
A free monthly electronic newsletter published by EAS Consulting Group, LLC for the industries regulated by FDA.
Pharmaceuticals · Medical Devices · Foods · Dietary Supplements · Cosmetics · Tobacco Products
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 September 2010
In this Issue
Upcoming EAS Events
  • Food Forum USA [more]
  • Supply Side West [more]
  • 2010 Regulatory Affairs Professional Society Annual Conference and Exhibition [more]
  • Dietary Supplement GMP Seminar [more]
  • China International Food Safety and Quality Conference [more]
  • Dietary Supplement Labeling Compliance Review Seminar [more]

From the Desk of the President
As FDA Begins Enforcement of the Egg Safety Rule

Ed Steele, President

Dear Reader,

Welcome to the September issue of EAS-e-News, our free newsletter for industries regulated by the Food and Drug Administration.

The two FDA Form 483 Inspectional Findings resulting from inspections at Wright County Egg and Hillandale Farms facilities in Iowa are the first we have seen as FDA begins enforcement of the new egg safety rule which went into effect in July—just too late to prevent a multi-state outbreak of salmonellosis. The agency says it will inspect some 600 facilities covered by the rule within the next 15 months, those with 50,000 laying hens or more. In fact, any food production facility regulated by FDA would find the two 483s instructive. Both companies, for example, had written prevention plans for Salmonella Enteritidis but failed to implement them.

The huge egg recall has also raised concerns among food companies that use egg ingredients in their products. In an August 30 press briefing, FDA Deputy Commissioner for Foods Mike Taylor warned that all egg ingredients need to be processed to kill Salmonella.

While FDA is caught up in a media storm over eggs, here at EAS we are steadily building our consulting team to better serve our U.S. and international clients. I would like to welcome aboard two new EAS consultants: Richard Phillips, who has an impressive resumé in quality assurance for pharmaceuticals; and Hae Rang Chung, our new representative in Seoul, Korea (see details below).

EAS has a growing business in Asia, notably in the Yellow River Delta region of northeastern China. Last month, we were represented at an international conference in Binzhou (about 200 miles south of Beijing) and we will be exhibiting at the upcoming China International Food Safety and Quality Conference in Shanghai, November 10-11.

We feature the pharma sector in our Issue of the Month article for September, in which Chris Celeste, EAS director of regulatory information and submissions, describes what FDA needs to know when there is a change of ownership in drug applications. This is a complex topic, so we have allocated extra space for details.

Publishers tell us that we have entered a new era in which communication is no longer just one-way but—ideally—involves an interaction between a writer and a community of readers. In this spirit, I invite you to comment on what you see in EAS-e-News and to share the newsletter with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
What to Tell FDA When Ownership of Drug Applications Changes

By: Charles Celeste, RAC, Director, Regulatory Information and Submissions

Drug applications are often included in the ever-growing world of mergers, buy-outs, joint ventures, acquisitions and the sale of assets or ownership. To address this issue, FDA created Guidance for the transfer of application ownership which appeared as a final regulation in the February 22, 1985, Federal Register.

New Drug Applications and Abbreviated New Drug Applications

The regulation in 21 CFR 314.72 specifically applies to new drug applications (NDA) and abbreviated new drug applications (ANDA). The regulation requires both the former owner and the new owner to notify the Center for Drug Evaluation and Research (CDER) reviewing division and to provide certain information.

The former owner needs to provide a letter to FDA stating the application and all rights to the application have been transferred and identifying the entity to which the application has been transferred. The letter needs to be signed by a responsible official of the company on the company’s letterhead stationary. This document should state when the ownership will be changed. Although the regulation does not require the former owner to assure FDA that a complete copy of the application has been provided to the new owner, such a statement helps assure FDA that outstanding issues will be addressed.

FDA will be more comfortable if this document is dated shortly before or on the day of the change. Retrospective letters on plain letterhead paper or the new company’s stationary by former officials do not give FDA the same level of assurance.

The new owner will need to submit a letter and an application form with the following:

  • an acknowledgment that he is the new owner of the application,
  • a commitment to agreements, promises, and conditions made by the former owner and contained in the application,
  • the date the transfer of ownership becomes effective, and
  • either a statement that the new owner has a complete copy of the application, including supplements and records required under §314.81 or a request under §20.45 for a complete copy (including supplements and reports to FDA).

If a copy of the application is requested, the new owner will incur costs for the copy.

To assure all documents by new and old owners are acted on together, it is helpful (but not required) to submit letters and forms from both parties--and any other relevant documents--in one envelope directed to the drug review division.

The new owner will need to advise FDA of any changes to the application as governed by§314.70. However, a labeling change in brand name and name and address of the manufacturer may be made in the annual report.

Investigational New Drugs

While, FDA does not have any specific requirements for change in ownership of an Investigational New Drug (IND) these applications would follow the same procedures as outlined above for NDAs and ANDAs. We would recommend contacting the FDA Project manager to inform them of the change in ownership.

Drug Master Files

Changes of ownership of Drug Master Files (DMFs) are not addressed in 21 CFR 314.72, but they should follow the same general procedures. DMFs are submitted to FDA for various purposes related to operations conducted at a particular manufacturing location. Changes in ownership of a manufacturing location relate to the DMF and the operations conducted there need to be reported to the FDA. Information about the change in ownership, managers and labeling should be submitted to FDA as an amendment to the DMF. The DMF holder should submit a letter informing FDA of the change and the new DMF holder should submit a letter informing FDA of the change. The letter should include a new: “Administrate Page”; “Statement of Commitment” and “Appointment of U.S. Agent” (if held by a foreign firm). As a good business practice, customers should be notified of the change of ownership and provided with assurance that business will continue with little or no interruption. Other changes that happen later as a result of the ownership change should be handled according to the Guideline for Drug Master Files, September 1989.

Other Regulatory Provisions

If the new owner is a new domestic company, the company must be registered. If the new owner is a foreign company and the site is outside of the U.S., the foreign company is required to register. However, a foreign company must also have an Appointed U.S. Agent, and this information must be submitted in a letter to the agency for inclusion in the application (IND, NDA, ANDA and DMF) file.

Each drug product whose ownership is being transferred to the new (domestic or foreign) company must be listed by the new owner. If the company does not have a Labeler Code for its National Drug Code (NDC) number, FDA will assign one. This will require the submission of an electronic labeler code request and an establishment registration request via FDA’s Electronic Submission Gateway.

Registration of a New Establishment and Product Listings

The regulations governing the registration of an establishment and product listing appear in 21 CFR 207. Although the regulation in Part 207 still references the use of FDA Forms 2656 and 2657, FDA now requires establishment registration and product listing to be done electronically. The agency has provided specific guidance and training on preparing and submitting these documents. Changes in a company name or ownership will require that the electronic files be updated and submitted to the FDA to reflect the changes. For additional information regarding electronic registration and product listing see EAS-e-News, December 2009.

Who's Who at EAS
Meet EAS Senior Consultant James Knight

James Knight

James H. Knight joined EAS in October 2008 as a senior consultant with more than 30-years’ experience in the pharma sector. His career began at Baxter-Travenol in Kingstree, South Carolina, where he established the site’s first GMP-compliant microbial limits testing laboratory. When the division was sold to Gist-Brocades, he became the analytical chemistry lab manager.

He joined Schering-Plough HealthCare Products in 1986, where he spent 14-years, establishing the first quality program for the division’s pilot production facility. He provided technical services for the company’s international business unit. In this prominent role, he worked with 70 offshore subsidiaries, licensees, and distributorships, providing support for new-product launches and line extensions, as well as GMP compliance advice.

In 1999, he launched his own consulting firm. A year later, he joined St. Jude Children’s Research Hospital as quality assurance director for the production of biologics used in the hospital’s clinical trials, while continuing his work as an independent consultant. He was responsible for writing and editing more than 200 Standard Operating Procedures, more than 200 Master Batch Records, and 200 Release Specifications within the first year. In 2006, the hospital established Children’s GMP, LLC where Mr. Knight continues to serve as secretary and QA director.

“James is a key member of our pharma consulting team with an extensive knowledge of GMPs and how to achieve regulatory compliance,” says EAS President Ed Steele.

What's New on FDA's Website
August Updates

Listed below are links to new additions to the FDA website for the month of August, 2010. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

FDA Press Announcements
Recalls and Safety Alerts
Congressional Testimony
Enforcement Reports
What's New by Topic

EAS in Action

EAS Goes to China

EAS Goes to China - Doug Nelson

EAS Senior Consultant Douglas Nelson delivered a presentation on low acid canned foods at the Binzhou International Sustainable and Economic Development Conference, held August 23-27 in Binzhou, Shandong Province, China.

EAS is pleased to offers services to food and dietary supplement firms in the Yellow River Delta, including assistance on labeling, seafood HACCP, GMPs, GAPs, low acid canned foods, food and color additives, food allergens, pesticide regulations and U.S. import procedures, among other issues.

“This conference was a great opportunity to showcase what EAS can do to facilitate the import-export business between China and the U.S.,” says Nelson, a former FDA Consumer Safety Officer who is a leading expert in the regulation of low acid canned foods. As an EAS consultant, he specializes in food sector audits and training.

In another upcoming activity in China, EAS will be an exhibitor at the China International Food Safety & Quality Conference and Expo in Shanghai, November 10-11. Dr. John Jones, former FDA international affairs official and Douglas Nelson will be manning the EAS exhibit booth at the Shanghai conference.

This meeting, which is now in its fourth year, is expected to attract more than 1,000 delegates from 18 countries. It includes an educational program with more than 70 presentations.

“China is becoming an increasingly important market for our services and this event provides an excellent forum for networking with key government and industry representatives,” says EAS President Ed Steele.

Photo above: Linda Zhou & Douglas Nelson

EAS Offers Services to KHIDI

KHIDI

EAS is proud to announce its collaboration with Korea Health Industry Development Institute (KHIDI), an agency of Korea’s Ministry of Health and Welfare.

The institute’s mission includes the promotion of Korea’s pharmaceuticals, cosmetics, food, medical devices, and healthcare sectors. KHIDI also operates a health technology transfer center, which explores opportunities for overseas technology transfer.

KHIDI is active in seeking business and license partners at various stages of early drug development. The institute works to help its client companies commercialize their technologies and products. Its other major activities include quality testing and evaluation, research planning and evaluation services, and export promotion.

“This alliance between EAS and KHIDI will open up many new business opportunities for our Korean clients,” says EAS President Ed Steele.

Dr. Hae Rang Chung Provides Link to EAS’s Korean Clients

Dr. Hae Rang Chung

Dr. Hae Rang Chung of Seoul, Korea—a former head researcher with the Korea Health Industry Development Institute (KHIDI) and a former visiting scientist at FDA’s Center for Food Safety and Applied Nutrition—is now collaborating with EAS to facilitate work with our Korean clients through KHIDI.

Dr. Chung’s career included almost six years as director of KHIDI’s Quality Evaluation Center (1999-2004). She spent two years as a visiting scholar at the University of Connecticut’s Department of Nutritional Sciences.

Since July 2007, Dr. Chung has been president of Nutrition for the Future, Inc., providing food and nutrition consulting services. She has a Ph.D in nutrition from Ewha Women’s University in Seoul.

“We are delighted to have Dr. Chung as our lead representative in Seoul,” says EAS President Ed Steele. “Her understanding of the regulatory environments in both the United States and Korea will be a major asset for our clients.”

Dr. Richard Phillips Strengthens EAS Pharmaceutical Team

Richard W. Phillips, Ph.D is the latest addition to the EAS senior consulting team. A former quality assurance manager for Merck & Co. Inc., and a former associate director of analytical development at Patheon Pharmaceuticals, Dr. Phillips has been a compliance consultant to the pharma industry since 2007.

He joined Merck in 1998 as a senior project chemist and progressed steadily in the organization to become QA manager, a position he held from January 2004 to March 2006. In his role as QA and release manager at Merck, he participated in audits by regulatory agencies, as well as by divisional QA and customers. This work included preparing personnel who were likely to interface with the investigators.

As president and principal quality consultant of LevoPharm Consulting LLC, he has conducted cGMP and mock pre-approval audits of international and domestic pharmaceutical firms. In addition, he has provided consulting services related to quality assurance, manufacturing operations, packaging operations, testing, stability program management, regulatory agency inspection readiness, and technical document review.

An accomplished athlete and scholar in his student years, he was awarded a full athletic scholarship for varsity football at the University of Richmond from 1987 to 1992, and received the university’s Analytical Chemistry Student of the Year Award in 1991.

“With his talent and his wealth of experience, Richard is an excellent addition to our fast-growing pharma consulting team,” says EAS President Ed Steele.

EAS-e-Docs
Latest Additions to the EAS-e-Docs Service

EAS-e-Docs

Here are the most recent additions to our new EAS-e-Docs service, which provides easy access to selected documents that we believe will help industry in complying with FDA’s laws and regulations:

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 to maintain 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.

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.

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.

GAO Report

New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials
This report reviews FDA’s use of evidence from non-inferiority trials to establish a drug’s effectiveness and support approval. The report (1) identifies the type and status of drug applications submitted for FDA review that included evidence from non-inferiority trials; (2) examines the characteristics of non-inferiority trials FDA considered in making approval decisions; and (3) describes FDA’s guidance for establishing a drug’s effectiveness on the basis of non-inferiority trials.

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 document describes FDA’s current policies with respect to civil money penalties and no tobacco- sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic 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 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.

A free copy of these and other valuable documents will be sent to you by email upon request from the EAS-e-Docs page of the EAS website. Click here for a full list of available documents.

Upcoming Events

Dietary Supplement GMP Seminar Rescheduled

Our scheduled mid-September dietary supplement GMP seminar will now be held October 26-27, 2010 at the EAS Training Facility in Alexandria, VA.

The seminar will cover the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

EAS Vice President Dean Cirotta and EAS Senior Consultant William Ment will lead this intensive training program to explain how to comply with FDA’s GMP regulations for dietary supplements.

This seminar is also available upon request on an in-house basis. Holding the seminar at your facilities can be very cost effective and it allows the program to be tailored to your particular needs.

Visit the EAS web site for more details.

Upcoming Events

Food Forum USA
Sept. 2, 2010
Hannover, Germany
Presenter: Gisela Leon

Supply Side West
October 19-23, 2010
Las Vegas, Nev.
Booth 24120

2010 Regulatory Affairs Professional Society Annual Conference and Exhibition
October 24-27, 2010
San Jose, Calif.
Booth 435

Dietary Supplement GMP Seminar
October 26-27, 2010
EAS Headquarters
Alexandria, Va.
(Contact EAS for details).

China International Food Safety and Quality Conference
November 10-11, 2010
Shanghai, China
(Contact EAS for details)

Dietary Supplement Labeling Compliance Review Seminar
November 16, 2010
EAS Headquarters
Alexandria, Va.
(Contact EAS for details).

Order Publications and Regulatory Tools

EAS Labeling Type Size Guide EAS Labeling Type Size Guide

A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.		 $ 9.00
Code of Federal Regulations, A pocket Guide

Dietary Supplement GMP Regulation -
A Pocket Guide

A 4"x6" bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.

 < 25 $ 10.00 each
25-50 $ 9.00 each
50-100 $ 8.00 each
> 100 $ 7.00 each
Dietary Supplement Labeling Compliance Review, 3rd edition Dietary Supplement Labeling Compliance Review, 3rd edition

A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell

Hardbound book		 $ 194.99
Food Labeling Compliance Review, 4th edition Food Labeling Compliance Review, 4th edition

A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell.

Hardbound book and CD		 $ 229.00 / set
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