FDA In Brief: FDA seeks public feedback on new drug approval transparency efforts

FDA In Brief: FDA seeks public feedback on new drug approval transparency efforts 

Today the U.S. Food and Drug Administration issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package Documentation, to open a docket for public comment as part of the agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process for drug and biological products assessed by the FDA’s Center for Drug Evaluation and Research (CDER). The notice specifically asks for feedback on the  Clinical Data Summary Report (CSR) Pilot Program and the new integrated review of marketing applications process and documentation template. The CSR pilot was launched in 2018 to assess the feasibility of publicly posting clear summaries of the safety and effectiveness information that is used to ...

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