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Sponsors that plan to seek approval based on a single trial and confirmatory data should discuss their development program with the FDA, the agency said. Read More
The Senate is racing to vote on a stopgap measure keeping federal agencies, including the FDA, funded through Dec. 3, a critical step in avoiding a shutdown set to occur Friday. Read More
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said his center continues to experience large losses of staff during the pandemic — possibly limiting CBER’s ability to achieve its goals for next year. Read More
AstraZeneca’s rare-diseases subsidiary Alexion has announced that it will acquire Caelum Biosciences, which nets the company a potentially first-in-class monoclonal antibody for the treatment of the rare disease light-chain (AL) amyloidosis. Read More
As part of its forward-looking initiative to drive greater use of real-world evidence (RWE), the FDA has issued detailed guidance for sponsors and researchers who intend to use electronic health records (EHRs) and medical claims to support drug approvals and post-approval requirements. Read More
The Cherokee Nation territory in Oklahoma has reached a settlement of $75 million with the three largest drug wholesalers in the U.S. over their alleged role in the opioid epidemic. This is the first settlement with a tribal government in the opioid litigation. Read More
In a rare move, the FDA has informed multiple drug sponsors that used two Indian contract research organizations (CROs) with concerning data integrity practices that the bioequivalence or bioavailability studies those firms conducted will need to be repeated elsewhere. Read More
The FDA has laid out its draft recommendations for designs, study populations and endpoints for clinical trials of drugs designed to treat naïve and refractory nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC). Read More
What type of notification the FDA will provide to a drug or biologics company that may not be complying with good manufacturing practices (GMP) depends on several factors, including the type of problem, the law and the agency’s internal regulatory procedures manual, agency officials said yesterday at the FDA/Parenteral Drug Association (PDA) joint regulatory conference. Read More