Master protocols that allow for the simultaneous study of multiple agents will shave more time off in the clinic than one-off studies in small groups of patients, FDA’s Janet Woodcock predicted. The current timeframes in oncology development are “unacceptable,” and can be shortened, she said, by “doing things differently.”
FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, gave some advice to drug developers looking to shorten the clinical development time for new treatments, particularly in oncology: it will be participation in innovative combination trials that will really cut development time – not simply conducting smaller, shorter studies of single agents.
Woodcock used the platform of an April 12 Friends of Cancer Research forum on Breakthrough Therapies to continue to push...
The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.
Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.
Manufacturers should use of nontraditional, randomized study designs and rigorous observational approaches to counter concerns about safety and effectiveness in low-risk populations, while also doing more to respond to the public’s questions about mRNA technology, legal and medical experts said.
The agency is expected to give its final verdict on the Barth syndrome drug by the end of September. Stealth is seeking accelerated approval based on the path forward outlined in the FDA's May 2025 complete response letter.
The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.
Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
