Posted by Michael Wonder on 26 Jun 2019
FDA seeks public feedback on new drug approval transparency efforts
26 June 2019 - Today the U.S. FDA 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.
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 make drug approval decisions. The goal of the program was to post portions of the clinical study reports from the drug company’s new drug application along with the drug review documents (action package) following approval. The recruitment phase of the pilot program has concluded.One drug company voluntarily agreed to participate.
