On Wednesday, the US Food and Drug Administration (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 (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 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.

Another effort that the FDA is working on is the integrated review process and documentation template, currently being implemented, that was developed as part of the FDA's ongoing New Drugs Regulatory Program Modernization, which is part of a multi-year, multi-phase effort to enhance the new drugs regulatory program in the FDA's Center for Drug Evalution and Research. The process and template are intended to promote integrated and interdisciplinary assessments, enhance clarity of assessments regarding the benefits and risks for new drug products, and improve communication about the basis for new drug approvals. The initiative includes the use and public posting, upon approval of a new drug or biologic, of an integrated review document that contains a summary, an integrated assessment, and appendices. The review template would replace the current documentation where each discipline provides a separate application review document. The FDA believes this initiative will also meet the goal of effectively communicating the basis for new drug approvals. The agency is therefore considering whether to focus its efforts to better communicate the basis for drug approvals on this review template effort, rather than on the release of CSRs and is seeking feedback on both of these programs through the docket.

The FDA has also updated the publicly available information about the New Drugs Regulatory Program Modernization on a new webpage that provides information about the initiative and the projects and programs in progress, including a section on the integrated review process and documentation template.

Related Information

• Federal Register: New Drugs Regulatory Program Modernization: Improving Approval Package Documentation
• New Drugs Regulatory Program Modernization
• FDA Proposes Process Modernization to Support New Drug Development

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.