PET DRUGS PROPOSED CGMP RULE AND DRAFT GUIDANCE Q&As

The FDA recently published a series of questions and answers related to PET drugs and the CGMP rule and draft guidance. The Coalition for PET Drug Approval is making the information published by the FDA available to stakeholders in an effort to address all issues related to the process and to assist the community in being able to meet the deadline for the licensure application process of December 12, 2011.  To view the FDA publication please click here or paste the URL into your Web browser: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085803.htm

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