FDA proposes controversial change in GMP

In mid-January 2006, FDA issued a proposed rule exempting phase I investigational drugs and biologics for human clinical trials from the requirement to follow CGMP regulations. FDA has issued a brief guidance with GMP recommendations for phase I (to replace the CGMP regulation), and a direct final rule to make the change in the event that they receive no significant adverse comments.

The proposed draft GMP guidance is highly controversial, particularly in terms of patient safety, product release, and facility, testing, and training requirements. Furthermore, it does not harmonize with European Union requirements.

Go to www.GMPTrainingSystems.com and click on Resources. Scroll down to INDs - CGMPs During Phase I Clinical Trials. Here you will find the Proposed Rule, the Direct Final Rule, and a new Guidance Document.

Comments are due to FDA by April 3, 2006.

Audio Seminar set for March 9.

We have arranged an Audio Seminar to discuss this proposal by FDA. Barbara Immel, Editorial Advisory Board Member for BioPharm International and Editor of The Immel Report, will lead the discussion at this important session. David Markovitz, President of GMP Training Systems, Inc., will be the Moderator.

Learn more about this Audio Seminar at www.GMPTrainingSystems.com. Click on Audio Seminars and find the session titled Chipping Away at the GMPs.

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