FDA Director Steven Galson presents CDER update

FDA Director Steven Galson presents CDER update

GMP News
21 March 2007

FDA Director Steven Galson presents CDER update

Steven K. Galson, Director, Center for Drug Evaluation and Research (CDER) has given a presentation at the American College of Preventative Medicine (Miami) which gives a good overview about recent CDER activities.

Based on an assessment of the Institute of Medicine (IOM), the agency has committed to strengthening the drug safety program "as rapidly and efficiently as available resources allow". Thus commitment is based on three interrelated themes:

  • Strengthening the science that supports our medical product safety system
  • Improving communication and information flows
  • Improving operations and management to strengthen the drug safety system

In this context, the U.S. Food and Drug Administration (FDA) has also started a pilot program to assess safety profiles of newly approved Products. The idea is to look at particular new molecular entities (NMEs) 18 months after approval and review data like adverse events, post marketing clinical trial data and periodic safety update reports to identify potential safety concerns.

On 2 March, the FDA has issued the "final guidance that describes FDA’s current approach to communicating drug safety information, including emerging safety information, to the public. The guidance also includes the factors that influence when such information is communicated… The guidance affirms the agency’s commitment to communicate important drug safety information in a timely manner, including in some situations when the agency is still evaluating whether to take any regulatory action."

The guidance on "Drug Safety Information-FDA’s Communication to the Public" is available on the Internet at FDA’s "Guidance Documents". For more information, please also see the FDA news.

In 2007, CDER will also begin to regularly publish summaries of results of FDA post marketing reviews and information on emerging safety issues. We will keep you informed.

Another part of the presentation was the 2006 application and approval wrap-up, giving an overview about the number of ANDA, standard and priority drugs approved and their median review time.

The differences between traditional and CMC Pilot NDA –Submissions were elaborated. Galson gave an impression about submission, review process and the regulatory outcome of the two application systems.

Further information can be found in the presentation.


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

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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