FDA will consider a regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA receives:
New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;
A request under § 60.24 for revision of the regulatory review period determination;
A due diligence petition filed under § 60.30; or
A request for a hearing filed under § 60.40.
FDA will notify PTO that the regulatory review period determination is final upon:
The expiration of the 180-day period for filing a due diligence petition; or
If FDA has received a request for a revision, a due diligence petition, or a request for a hearing, upon resolution of the request for a revision, the petition, or the hearing, whichever is later. FDA will send a copy of the notification to the applicant and file a copy of the notification in the docket established for the application in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
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