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.

Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news