FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process

By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval. At the same time, FDA is implementing initiatives to enhance its own review process efficiency to improve the speed and predictability of the generic drug review process while maintaining our rigorous scientific standards.

To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan

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FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process

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