FDA - CBER Releases Strategic Plan for 2012-2016

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Just released, the FDA CBER Strategic Plan for Regulatory Science and Research

CBER Releases Strategic Plan for 2012-2016 Period - RAPS - News - Article View:

"CBER’s plan outlines six core strategic goals it says will guide it through the next five years:

1. Increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza and emerging infectious diseases
2. Improve global public health through international collaboration including research and information sharing
3. Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
4. Ensure the safety of biological products
5. Advance regulatory science and research
6. Manage for organizational excellence and accountability"

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FDA Draft Guidance - Medical Device ISO - Voluntary Audit Report Submission Program

The Federal Register notice just announced the availability of the FDA Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

The medical device ISO 13485:2003 Voluntary Audit Report Submission Program outlined in this draft guidance is another way in which FDA may leverage audits performed by other Global Harmonization Task Force (GHTF) regulators and accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

The FDA recommends that a domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation be eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Program under certain circumstances described on the FDA webpage (link provided above).

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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

---  the original post follows below  ---

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. 

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