(1998; 18 pages)
Positron Emission Tomographic (PET) products - exemptions to CGMP: final rule revoked
United States of America. The Food and Drug Administration has revoked its final rule allowing approval to be granted to requests submitted by manufacturers of positron emission tomography (PET) radiopharmaceutical drug products for exceptions or alternatives to provisions of the current good manufacturing practice regulations.
Two guidance documents have also been revoked:
- "Draft Guideline on the Manufacture of Positron Emission Tomography Radiopharmaceutical Drug Products" and the final version of this document:
- "Guidance for Industry: Current Good Manufacturing Practices for Positron Emission Tomographic (PET) Drug Products".
This action has been taken because, in accordance with the Food and Drug Administration Modernization Act of 21 November 1997, the FDA has been directed to develop new drug approval procedures for PET radiopharmaceutical drug products together with current good manufacturing practice requirements for such drugs, taking into account any relevant differences between not-for-profit institutions that compound PET drugs and commercial manufacturers.
The FDA is to establish these procedures and requirements not later than 2 years after the date of enactment. In doing so, the agency must consult with patient advocacy groups, professional associations, manufacturers and persons licensed to make or use PET drugs.
[See also Pharmaceuticals Newsletter Nos. 9&10, September&October 1997]
Reference: Federal Register 62(244): 66522-3 (1997).