The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
Starting February 2023, The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
FDA fills in the details with guidance for Marketing Status Notification
In 2017, the Reauthorization Act (FDARA) made it mandatory for drug marketing holders to notify the FDA about the status of the NDA or ANDA product withdrawal. The FDA releases guidance on how to update the FDA appropriately.