FDA sends ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating certain...
Pharmaceutical Research and Manufacturers of America suggests things for FDA to consider as it moves forward from a March workshop on negative control...
The Council for Responsible Nutrition asks FDA to reconsider how it uses the drug preclusion clause in the Dietary Supplement Health and Education Act...
FDA approves expanded Magnetic Resonance Imaging labeling for Abbotts Eterna spinal cord stimulation (SCS) system to include new leads that are magnet...
FDA publishes a Study Data Technical Conformance Guide with specifications, recommendations, and general considerations on how to submit standardized ...
Four pharmaceutical stakeholders recommend changes to an FDA question-and-answer draft guidance on electronic systems, records, and signatures.
FDA orders safety labeling changes for prescription stimulants used to treat attention deficit/hyperactivity disorder and other conditions.
Federal Register notice: FDA announces a 6/16 Oncologic Drugs Advisory Committee meeting of its Pediatric Oncology Subcommittee that will discuss dosa...
