Monthly Archives: August 2011

Update: Q & A from FDA Meeting on March 2, 2011

The Coalition for PET Drug Approval has compiled questions and answers that were posed during the FDA Public Meeting on March 2, 2011.

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New FDA cGMP Guidance for Small Businesses Available

The Food and Drug Administration (FDA) has announced the availability of a guidance for small business entities entitled “PET Drugs— Current Good Manufacturing Practice(CGMP); Small Entity Compliance Guide.” The guideline is intended to help small businesses better understand FDA’s thinking … Continue reading

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