Generic Reviews Steaming Ahead, But Are Storm Clouds On The Horizon?

FDA's generic office director notes a jump in year-end submissions – and a jump in refuse-to-receive actions.

ORLANDO – Was December just a bit of holiday indulgence for the generic industry, or were the end-of-year submissions the beginning of a trend that could fuel friction between industry and FDA?

FDA's Office of Generic Drugs Director Kathleen Uhl didn't address the question at the Generic Pharmaceutical Association's annual meeting on...

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