Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology

Read the full article: Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology:

"Michael Kopcha, a pharma industry veteran with 25 years of experience in formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management, has been named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ), according to a Sept. 25, 2015 announcement by Janet Woodcock, director, Center for Drug Evaluation and Research (CDER). Kopcha will join CDER in November pending ethics clearance.

FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions."

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FDA - Pharma Warning Letters and Notice of Violation Letters

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Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

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FDA Drug Identification Service

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I was surprised to discover this service. According to the FDA Drug Identification webpage:

"Division staff can identify drugs for you based on physical appearance (color, shape, size, etc.) and markings. Email DDI your drug description at druginfo@.fda.hhs.gov. 

We will identify drugs for you as soon as possible. However, please note that this is not an emergency service. In the case of an emergency, please contact the Poison Control Center 1-800-222-1222."

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FDA Warning - Lipodissolve Products

The FDA has sent sent warning letters to six medical spas in the United States - and a cyber letter to a company in Brazil - for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

 Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research (CDER) says:

"We are concerned that these companies are misleading consumers. It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal."

The FDA website provides more information on the topic, FDA Warns About Lipodissolve Product Claims, with a downloadable pdf. 

I'm not a big fan of liposuction, let alone this approach using lipo-dissolving chemicals.

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Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

• Agenda (PDF - 64KB)
• Registration form (PDF - 20KB)

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

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FDA - Preparation Tips For Meetings With The FDA

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If you have upcoming meetings with the FDA, or are looking for ways to be more effective during the meeting, then this slide deck is a must read, Strategies to Prepare for Meetings with the FDA by Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA (circa 2006). In summary, she highlights these 3 things:

• Meetings Are a Critical Component of the Way We (Industry and FDA) Do Business
• Extensive Framework Around Meeting Process and Procedures Enhance Predictability
• Efficient Use of Meetings Facilitates Our Shared Public Health Goal

Related Posts: FDA Guidance - FDA and Sponsor-Applicant Meetings

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FDA Guidance - FDA and Sponsor-Applicant Meetings

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Updated October 24, 2022

The original link broke.

There are many FDA guidance documents intended for meetings between the FDA and Sponsors or Applicants.

You can find them by searching the FDA website:

Search for FDA Guidance Documents - FDA.gov

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This FDA guidance, Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants, provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference). This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible. This guidance supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000. The 2000 guidance implemented section 119(a) of the Food and Drug Administration Modernization Act of 1997, and reflected a unified approach to all formal multidisciplinary meetings between sponsors or applicants and the FDA. 

Related Posts: Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf) FDA Draft Guidance - Drug Supply Chain and SNIs FDA Final Guidance On Genetically Engineered Animals FDA Draft Guidance On Good Importer Practices FDA Guidance Documents - FDA Current Thinking (free) 

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FDA Updates MAPP On Human Research

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Updated October 27, 2022

The original links broke.

You can still learn more at:

CDER Manual of Policies & Procedures | MAPP - FDA.gov

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This FDA Manual of Policies and Procedures (MAPP) establishes the policies and procedures that employees in the Center for Drug Evaluation and Research (CDER) must follow when submitting human subject research for review to FDA’s Institutional Review Board (IRB), the Research Involving Human Subjects Committee (RIHSC), in the Office of Science and Health Coordination (OSHC) within the Office of the Commissioner. These procedures must be followed, and written RIHSC approval or exemption obtained, before initiating any research involving human subjects. This MAPP also establishes policies and procedures pertaining to responsibilities for study conduct and oversight.

This MAPP is a revision of an earlier MAPP originally numbered 4112.6. The MAPP’s change in number reflects the establishment of the Office of Translational Sciences (OTS) within CDER.

Additional FDA Resources:

• 45 CFR part 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Office of the Secretary, HHS, April 18, 1979 (the Belmont Report) http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
• "Federal-wide Assurance of Protection for Human Subjects," OHRP, HHS http://www.hhs.gov/ohrp/assurances/assurances_index.html
• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (http://privacyruleandresearch.nih.gov/pr_02.asp)
• Information Sheet Guidances - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

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FDA Publishes Rulemaking Histories For OTC Drugs

If you're in the Over-The-Counter (OTC), non-prescription drug business, then this FDA collection might be of some interest to you: Rulemaking History for Nonprescription Products: Drug Category List. The Over-the-Counter (OTC) drug category collection contains Federal Register notices organized by therapeutic category subtopics. Each child collection links to therapeutic category pages organized chronologically. Pretty nice. For example, you can scan the Federal Register history for something like, Hair Growth and Loss, Male Genital Desensitizers, or Weight Control. 

Related Posts: FDA Warning - Anesthetics On Skin Can Harm FDA Alert - Bowel Cleanser Warning Cold Meds For Kids - The FDA Weighs In Again 

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About The FDA Orange Book - Slide Deck (free)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .

• What is the Orange Book?
• What is exclusivity and how does it work?
• How is the Food and Drug Administration (FDA) involved with patent protection?

Related Posts:
FDA Orange Book - Online

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How The FDA Regulates Botanical Drugs

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You have to read this. In an issue of Nature Biotechnology, you'll learn how FDA personnel review applications to test botanical drugs in humans, and market those products in the US as reported in this article, "New therapies from old medicines - Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met (pdf)." In general, here's what it's all about . . .

1. From dietary supplements to new drugs
2. Current US regulatory environment
3. Review of botanical applications at CDER
4. Analysis of botanical drug IND submissions
5. Unique regulatory issues
6. Botanicals as variable, complex mixtures
7. Botanicals as multiple-plant combinations
8. Previous human use of botanicals
9. Botanicals marketed as dietary supplements

It's encouraging to me to see these kinds of articles appearing on the topic. Personally, I'd consider using more botanicals if I can see that some form of rigor is applied to them.

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