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.
Federal Register notice: FDA issues an order permanently debarring Maria Anzures-Camarena from providing services related to an approved or pending dr...
Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were no longer marketed....
FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.
