FDA Questions Value of Single-Arm Studies for Cancer Approvals

Pharmaceutical Drugs: Approval Timelines And The FDA - Healthcare Business Today

The journey from laboratory discovery to pharmacy shelf is a complex and often lengthy process in the United States. The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring that pharmaceutical drugs are safe and effective before they reach the public. However, the traditional approval timelines have come under scrutiny, especially when ... Read more The post Pharmaceutical Drugs: Approval Timelines and the FDA appeared first…

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session - The Cancer Letter

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office. This content is for Group 1 - Individual Seat, Individual Subscription - Annual ($555), Individual Subscription - Monthly ($55), Introductory Subscription - non-renewing ($60), and Sponsored accou…

Navigating the FDA’s accelerated approval pathways for oncology drugs

At CTO West Coast, an expert discussed the implications of the FDA’s expedited approval programmes with a spotlight on oncology.The post Navigating the FDA’s accelerated approval pathways for oncology drugs appeared first on Clinical Trials Arena.

FDA Questions Value of Single-Arm Studies for Cancer Approvals

On day 2 of an FDA advisory meeting to consider a new treatment for non–muscle invasive bladder cancer, an FDA official warns of the implications of approving based on a single-arm trial. Medscape Medical News