Regulatory Focus™ > News Articles > FDA Releases New Draft Guidance on PET Drug Products

FDA Releases New Draft Guidance on PET Drug Products

Posted 27 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new draft guidance 27 February on Positron Emission Tomography (PET) drug products.

FDA notes that Guidance: FDA Oversight of PET Drug Products Questions and Answers "provides [98] questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees."

Comments on the draft guidance are due by 29 May 2012.


Read more:

Guidance: FDA Oversight of PET Drug Products Questions and Answers

Federal Register - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability


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