ADDITIONAL INFORMATION PROVIDED BY FDA

In response to an inquiry, the Food and Drug Administration (FDA) has answered several remaining questions.

In response to an inquiry from the Coalition for PET Drug Approval, Elizabeth Giaquinto of the FDA has answered the following lingering questions:

Has the deadline for filing an ANDA/NDA for N-13 Ammonia been extended? If so, what is the Agency’s new deadline? What should a site do if they are unable to submit a completed deadline by the December 12th deadline?

In response to both of these questions, FDA has decided that for the next six months, until June 12, 2012, FDA does not intend to take enforcement action against a PET facility currently producing any PET drugs for clinical use for failure to submit a new or amended drug application by December 12, 2011, provided that the facility complies with all other FDA requirements, including CGMPs.

FDA will not exercise enforcement discretion after June 12, 2012. Therefore, if a facility wishes to continue to produce PET drugs for clinical use after June 12, 2012, they must have submitted an NDA or ANDA by that data, or be producing drugs under an IND. PET facilities who are unable to submit an NDA or ANDA by June 12, 2012 or operate under an IND must find a new supplier who has submitted an NDA or ANDA. This policy is applicable to all PET drugs, including N-13 Ammonia.

Is the electronic Common Technical Document (eCTD) format required for submission?

FDA does recommend that electronic submissions (which are preferable because they facilitate FDA’s review of the application) follow the CTD format. Paper submissions must be organized in the CTD format.

How would an entity expand into a new location (or add a new production module) after the filing deadline?

Please refer to the chart for current thinking on this issue: FDA Current Thinking on Changes to Facilities or Equipment

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