Blog Tag
3 articles tagged with Drug Approval. The newest post is from Apr 17, 2026.
In the fast-paced world of biopharma, where revolutionary drugs hold the potential to transform lives, every milestone matters. One such milestone, the Prescription Drug User Fee Act (PDUFA), plays a crucial role in shaping the landscape of drug development and impacting the often-volatile stock prices of these companies.
An AdCom, short for advisory committee meeting, is a public meeting where the FDA asks a panel of outside experts to review a drug, biologic, or medical product and discuss key questions related to safety, efficacy, labeling, or overall benefit-risk balance. These meetings do not directly approve or reject a product, but they can heavily influence perception around the regulatory path.
PDUFA stands for the Prescription Drug User Fee Act, a US law that allows the FDA to collect fees from drug manufacturers in exchange for defined review timelines and performance goals. In everyday biotech and investing language, however, "PDUFA" usually refers to a PDUFA date, which is the target date by which the FDA is expected to take action on a drug application.
