Home > Newsletters > International Pharmaceutical Regulatory Monitor > Gottlieb Speech Signals a Sea Change In FDA Drug Safety Strategy, Advocate Says
International Pharmaceutical Regulatory Monitor
July 2006 | Vol. 34 No. 7
Gottlieb Speech Signals a Sea Change In FDA Drug Safety Strategy, Advocate Says
A senior FDA official’s speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA’s thinking on drug safety, an industry observer says.
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