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Jun 12 2012

PET Drugs – Time to file that NDA, ANDA or IND

Deadline

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No more Nice Guy.  FDA is stopping Enforcement Discretion for facilities producing positron emission tomography (PET) drugs for clinical use effective Tuesday, 12 June 2012.

The long and tortured history of PET Drug products regulation began in 1997, when Congress passed the Food and Drug Administration Modernization Act (FDAMA).  One of the sections in this Act directed FDA to establish approval procedures and current Good Manufacturing Practices (cGMP) requirements for PET drugs.

In 2009, FDA finalized the procedures and requirements for PET drugs and mandated that, within 2 years, a facility must submit an NDA or ANDA for any PET drug marketed for clinical use.

Two years later, with the deadline looming, FDA received numerous requests to extend the submission deadline for submission of NDA and ANDAs.  FDA was concerned about preventing access to the PET drugs, and therefore issued a Notice of FDA Exercise of Enforcement Discretion for PET Drugs on 06 December 2011.  In the notice, FDA extended the deadline to file an NDA or ANDA for PET drugs to 12 June 2012.

Now, that grace period is over.  FDA will no longer exercise enforcement discretion for PET drugs for clinical use after Tuesday, 12 June 2012.

Here is the take-home message; as of 12 June 2012, all producers of PET drugs for clinical use must be:

  • Operating under approved NDA or ANDA or
  • Have submitted NDA, ANDA or IND

This is a post by Will Lee, Ph.D. Will is the Senior Director, Regulatory Affairs at Cato Research.