WebMar 15, 2024 · Today, the FDA announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27-29 to discuss six indications granted … WebApr 6, 2024 · In an important update to its policies for conducting clinical trials to support accelerated approval of oncology and other life-saving thereapies, FDA is articulating a preference for randomized controlled trials (RCTs), as opposed to single-arm studies, to support fast approvals of breakthrough drugs. A new draft guidance on “Clinical Trial ...
Federal Register, Volume 88 Issue 58 (Monday, March 27, 2024)
WebMar 24, 2024 · For Immediate Release: March 24, 2024. Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics ... WebApr 12, 2024 · A commentary in the New England Journal of Medicine from 2024 describes the concepts that were incorporated into the guidance. The FDA’s Oncology Center of Excellence also kicked off the initiative Project Confirm, which is intended to push for transparency regarding outcomes in Accelerated Approval for cancer therapies, as … tom zatina retires
Proposed FDA guidelines to strengthen oversight on accelerated …
WebFDA-2024-D-0110 Issued by: Oncology Center of Excellence The purpose of this guidance is to provide recommendations to sponsors of anti-cancer drugs or biological products … WebMar 28, 2024 · The FDA has issued draft guidance to improve applications for accelerated approvals, according to recently issued news release. The agency seeks to improve the … WebMar 29, 2024 · The draft guidance, published in the Federal Register on March 27, outlines recommendations for cancer drug sponsors that intend to seek an accelerated approval. The FDA’s goal is to beef up the design of these clinical trials by, for instance, conducting more randomized controlled trials (RCTs) and fewer single-arm trials. Over the past few ... tom zavoral