Federal Register notice: FDA makes available a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and B...
Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Content and Format.
Two stakeholders provide comments on an FDA public hearing on biologic product marketplace competition.
Six drug companies give FDA comments and recommendations on a draft guidance on using liquids and/or soft foods as drug administration vehicles.
A study of pediatric exclusivity trials finds that they have yielded useful information, but at a very high cost to consumers.
FDA clears an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that can be surgically implanted from antegrade or retrog...
HHS cancels an FDA fetal tissue contract with Advanced Biosciences Research and opens an investigation into all fetal tissue research.
FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of radiopharmaceuticals.