July 1, 1998

FDA Guidance On Pediatric Study Exclusivity

Arnold & Porter Article
FDA has now issued its guidance on qualifying for pediatric exclusivity. It includes, inter alia , the following notable points:

1) Exclusivity will not be granted for studies that were submitted before the FDA requests them.

2) Exclusivity may be granted for studies completed before the request, if submitted thereafter.

3) Exclusivity will cover all products containing the same active moiety as the one studied for which the party doing the study has approval.

4) Written requests for studies must be signed by an Office Director.

5) Applicants are encouraged to propose to FDA that it request pediatric studies for their drugs. For approved drugs, relative priority will be granted to drugs for which patents or exclusivity expire before March 31, 1999, so long as FDA receives the proposal by August 31, 1998.

FDA will entertain comments on the new guidance for 90 days after notice of availability is published in the Federal Register.

Please contact Don Beers (202-942-5012) or David Korn (202-942-5676) if you have questions about the guidance or would like to discuss its applicability to particular circumstances.

The guidance may be accessed by clicking on the highlighted word in the first paragraph or at .
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