WebApr 10, 2024 · The FDA’s latest draft guidance does just that: refining the agency’s thinking on the use of single-arm trials and randomized controlled trials (RCTs) for the accelerated approval of oncology therapies. If the draft guidance is finalized, oncology clinical trial sponsors will need to adjust their approach to the accelerated approval process ... 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 A new draft guidance on “Clinical Trial ...
FDA guidance impacts accelerated approval for oncology drugs
WebMar 24, 2024 · SILVER SPRING, Md., March 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued draft guidance,Clinical Trial Considerations to Support Accelerated Approval of Oncology ... WebMar 24, 2024 · "The FDA's accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing," said Richard Pazdur , MD, Director of the FDA's Oncology Center of Excellence. "Today's draft guidance provides recommendations to sponsors for designing clinical trials to support … questi wow addon
Federal Register, Volume 88 Issue 58 (Monday, March 27, 2024)
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 … WebMar 10, 2024 · On Thursday (March 9, 2024), the FDA sent a new guidance document entitled “ Clinical Trial Considerations to Support Accelerated Approval of Oncology … WebMar 24, 2024 · FDA draft guidance impacts companies using accelerated approval for oncology drugs Mar. 24, 2024 1:01 PM ET Pfizer Inc. (PFE) , GILD , MRK , BMY AMGN … questism read newest