FDA Guidance for Industry: PET Drug Products - CGMP / Small Entities Compliance Guide
Title:
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/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM266640.pdf
Content:
This draft guidance is intended to help PET drug producers better understand FDA’s thinking concerning compliance with the proposed CGMP regulations.