FDA Withdraws Controversial Rule

In 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FDA announced today (May 1) that this proposed rule is being withdrawn because significant adverse comments were received.

We conducted an audio seminar on this controversial change on March 9, approximately three weeks before the deadline for comments. We had an impact! Our session was called Chipping Away at the GMPs: Understanding FDA's Proposal to Exempt Material for Phase I Clinical Trials from CGMP Regulations.

Our guest presenter, Barbara Immel, presented an impressive argument that this move to exempt phase I investigational drugs and biologics was not a good idea.

Apparently, enough of you agreed and let the FDA know your thinking.

Read FDA's announcement withdrawing the rule at www.gmptrainingsystems.com/asp/resources.asp

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If you missed last week's audio seminar - Effectively Implementing Process Analytical Technology (PAT), you can purchase the CD, handouts, and written transcript of this popular program.

Go to www.gmptrainingsystems.com/asp/lcgc_archives.asp to find it as well as our other archived audio seminars.