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The Division of Bioequivalence (DBE) in the FDA’s Office of Generic Drugs hopes the addition of more reviewers will help reduce the long wait for generic drug application approvals, according to the division’s chief.
Generic firm Mylan Pharmaceuticals will seek an immediate appeal of a federal court ruling that prevents it from an early launch of a generic version of Johnson & Johnson’s pain-drug patch, Duragesic.
The FDA intends to discontinue the use of approvable letters and not-approvable letters for drug marketing applications and instead use “complete response letters” to indicate the review cycle is complete but the application is not ready for approval, the agency announced yesterday.
GlaxoSmithKline (GSK) filed a citizen petition with the FDA that is delaying final approval of a generic version of the company’s profitable allergy nasal spray drug Flonase, generic drug sources said.
The FDA has released an International Conference on Harmonisation guidance addressing issues related to the quality section of the common technical document (CTD-Q).
Saying the industry has failed to give it sufficient input, the FDA last week reopened the comment period for a notice on time estimates for collecting information for reporting manufacturing changes on approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
To help generic drug manufacturers determine if they are eligible for marketing exclusivity, the FDA will soon list on its website the date it receives the first substantially complete new drug application challenging a patent on a brand drug.