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Sally Choe, director of the FDA’s Office of Generic Drugs (OGD), will be stepping down from the agency on Oct. 8, and Susan Rosencrance, director of the Office of Lifecycle Products within the Office of Pharmaceutical Quality, has been tapped to replace her as acting OGD head. Read More
FDA leaders in oncology want sponsors seeking accelerated approval (AA) for cancer drugs to use new trial designs that will make the whole process more efficient and ultimately safer for patients. Read More
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More
Paxlovid is currently FDA-authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee agreed yesterday — somewhat grudgingly — that Rebyota (RBX2660), Rebiotix’s standardized fecal microbiota suspension, is a safe and effective treatment for recurrent Clostridium difficile infections (CDI). Read More
In another move to address the opioid crisis, the FDA has issued a guidance — effective immediately — that clarifies some supply chain requirements for the overdose treatment Naloxone (naloxone hydrochloride) to help make the treatment more accessible. Read More