FDA Ruling on cGMP for PET Drugs, 21 CFR 212
The FDA released the new cGMP for PET drugs on December 9, 2009, which will require all [18F]Fludeoxyglucose, [18F]Sodium Fluoride, and [¹³N]Ammonia manufacturers to register and submit a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) and obtain FDA approval to market [18F]FDG, [18F] Sodium Fluoride, or [¹³NAmmonia in the United States. The deadline for making the application is December 12, 2011. The NDA submission route has the potential burden of user fees under the Prescription Drug User Fee Act (PDUFA).
In 2006, labeling changes for [18F] FDG were made to alleviate conflicts between approved labeling and several formulations present in the marketplace. These changes may increase the number of [18F]FDG formulations and approved NDAs available under which an ANDA can be submitted. There are currently no user's fees associated with filing an ANDA.
Past and Current SNM Activities
The SNM conducted a survey of PET drug manufacturers in an effort to determine how many manufacturers there are and their end-product specifications in an effort to establish where commonalities exist. The SNM also met with representatives of the FDA in April 2010 to discuss concerns about stakeholders being able to meet the application deadline and the lack of information being provided for the application process. An overview of the minutes of that meeting is available on the link below:
The SNM collaborated with the FDA and the RSNA to co-sponsor the workshop entitled Two Topic Imaging Workshop: Day One - Standards for Imaging Endpoints in Clinical Trials, Day Two - Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products, on April 13–14, 2010. The presentations from this important and informative meeting are available at:
To further aid the community, the SNM created a public forum to encourage discussion among manufacturers. The 21 CFR 212 PET Regs – Public Updates forum will also be used by the SNM to post important announcements. To access the forum click here and then click on the 21 CFR 212 PET Regs - Public Updates link.
Recently the SNM joined the Coalition for PET Drug Approval along with 8 other 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 or ANDAs, and to make a positive impact on the overall implementation process through interaction with the FDA. The coalition is aggressively working with numerous organizations in an effort to provide stakeholders with information they will need in order to meet the deadline for submitting applications by December 12, 2011. The SNM has made, and continues to make, numerous contributions that will lead to the success of the coalition.
Website for Information about PET Drug Approval
Information about the PET drug approval process is now being provided on a website sponsored by the Coalition for PET Drug Approval. To access the website please click here or paste this URL into your Web browser: http://coalitionforpetdrugapproval.org/
In the Federal Register for February 3, 2011, the FDA published draft guidance on positron emission tomography drug applications. To view this information please click here or paste this URL in your Web browser: http://edocket.access.gpo.gov/2011/pdf/2011-2314.pdf