FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Unveils Plans to Encourage Complex Generics

Feb. 7, 2019

FDA Commissioner Scott Gottlieb announced the agency’s plans to promote complex generic drugs in 2019.

Complex drugs often have few competitors because they are harder to genericize using normal methods due to the complexities of their formulations, delivery systems or active ingredients, he said.

To encourage competition, the agency plans to issue additional guidance for developing specific complex generic drugs. It also intends to address complex drug categories that are difficult to copy because of their formations or mode of delivery.

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