Current FDA Activities

Current FDA Activities

GMP News
03 April 2007

Current FDA Activities


The U.S. Food and Drug Administration recently revised the "Newsroom" on their homepage which is a great overview about current FDA activities. Besides press releases and an overview of recalls and alerts information, several links are listed to news sorted by topic. The newsroom page also provides a short track to speeches of FDA representatives and congressional testimony – a good source to get an impression of FDA’s current thinking and development.

Content of the Newsroom:

  • Hot topics
  • FDA Press Releases
  • Recalls & Alerts
  • Public Notices
  • Speeches & Testimony
  • About FDA (e.g. annual reports, budget)
  • Regulatory Actions (E.g. Warning Letters, Product Approvals)
  • What's New by Topic

Further information you will find directly in the


The authority also published an overview of the GMP guideline revisions planned for 2007. On the list are two guidelines the industry has been waiting for: Quality by Design in the category Chemistry and Process Validation – General Principles and Practices in the category Compliance.

More detailed information on the 2007 guidance revisions you will get at the

FDA Guidance Agenda.


Learn more about the FDA and its regulations and how to prepare for inspections – in the following ECA courses:

FDA – what you need to know (Organisation, Inspection, Application and Approval)
Prague, Czech Republic from 26 - 27 April 2007

How to Pass EU and FDA Inspections – GMP-Compliance Auditor Course

Vienna, Austria, from 29 - 31 October 2007


Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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