FDA denies a 2019 Novartis petition asking for specific requirements for ANDA applicants citing Entresto as the reference-listed drug.
OptumHealth Care Solutions recalls (Class 1) its Nimbus II Plus infusion pumps due to multiple potential failure modes that may include battery failur...
FDA says an agency reorganization changing the operation of the Office of Regulatory Affairs is scheduled to take effect 10/1.
CDER Office of Medical Policy director Khair ElZarrad uses a podcast to discuss the benefits and challenges of using artificial intelligence in drug d...
CDER posts a list of 10 things it says people should know about the Centers pharmaceutical quality function.
Medline Industries recalls (Class 1) its Medline Sub-G Endotracheal Tube with Subglottic Suctioning after complaints were received about the devices i...
A bipartisan group of 11 Senate and House members asks FDA to require hearing aid labeling to disclose if the device uses proprietary software that af...
The International Council on Harmonization publishes the M12 final guideline on drug interactions and an accompanying question-and-answer document.
