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FDA Guidance for Industry: PET Drug Products - CGMP / Small Entities Compliance Guide

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Content:
This draft guidance is intended to help PET drug producers better understand FDA’s thinking concerning compliance with the proposed CGMP regulations.

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