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Year-End Filing Deadline Causing a Flurry of Activity for PET Drug Makers and Regulators

Mar 27th, 2011

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A December 12, 2011 filing deadline for new and abbreviated new drug applications (NDAs/ANDAs) for all positron emission tomography (PET) drugs currently in commercial clinical use is putting heat on manufacturers and FDA to address the outstanding quality regulatory issues for this unique and challenging class of high-tech injectable products.

FDA held a public meeting in early March at its White Oak campus to discuss the implications of the new rules on PET drug registration, listing, and inspection.  The discussions have relevance for the other similarly high-tech products now emerging onto the agency’s radar screen.

The Federal Register announcement stated that the agency was holding the meeting in part because it “recognizes that many PET producers are unfamiliar with the drug approval process.”

The chair of the meeting, CDER Office of Regulatory Policy (ORP) Associate Director Jane Axelrad, commented in her introduction that the agency is “sensitive to the fact that we are bringing under regulatory control an industry that had been largely unregulated and an industry with special characteristics.”

The meeting focused primarily on the three most common PET drugs currently being used:  fludeoxyglucose (FDG) 18, ammonia N 13 and sodium fluoride F 18.

In February, FDA issued a draft guidance providing its expectations for the content and format of NDAs and ANDAs for these three products to help manufacturers meet the upcoming deadline.

[More on the history of PET drug regulation and the discussion at the workshop on how to decide what type of application to file is provided for subscribers beginning on page 2.   Also see the IPQ “In the News” companion story on recent FDA PET drug inspection findings and GMP expectations.  Nonsubscribers may purchase the stories for $95 each by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here].

See related IPQ coverage:

Airport Radiation Screening-Induced Recall Highlights PET Drug GMP Challenges; FDA Releases PET Media Fill Guidance

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