March 21, 2011
In the Federal Register on February 3rd the FDA announced that they will hold a public meeting on the topic of how to successfully make application for an NDA and/or ANDA. The public meeting will be held at the FDA White Oak Campus in Silver Spring, Maryland, from 8:30 a.m. to 5:00 p.m. on Wednesday, March 2, 2011. The Coalition for PET Drug Approval is preparing to attend and actively participate in the public meeting.
To view the Federal Register announcement for the meeting please click here or paste this URL in your Web browser: http://edocket.access.gpo.gov/2011/pdf/2011-2313.pdf
To view the Federal Register information for draft guidance on positron emission tomography drug applications please click here or paste this URL in your Web browser: http://edocket.access.gpo.gov/2011/pdf/2011-2314.pdf
Last November the Coalition for PET Drug Approval was formed with the SNM being one of nine member organizations. The purpose of the coalition is to help our community understand requirements related to the implementation of 21 CFR part 212 and the submission process for PET NDAs (new drug applications) or ANDAs (abbreviated new drug applications) and to make a positive impact on the overall implementation process through interaction with the FDA. Current FDA regulations require that all manufacturers of PET drugs submit a license application no later than December 12, 2011. PET drugs are used in nuclear medicine imaging facilities everywhere and are an integral component of the imaging process.