The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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


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

This draft guidance is intended to help PET drug producers better understand FDA’s thinking concerning compliance with the proposed CGMP regulations.

Go back

GMP Conferences by Topics