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FDA denies a 2019 Novartis petition asking for specific requirements for ANDA applicants citing Entresto as the reference-listed d...[ Price : $8.95]
OptumHealth Care Solutions recalls (Class 1) its Nimbus II Plus infusion pumps due to multiple potential failure modes that may in...[ Price : $8.95]
FDA says an agency reorganization changing the operation of the Office of Regulatory Affairs is scheduled to take effect 10/1.[ Price : $8.95]
CDER Office of Medical Policy director Khair ElZarrad uses a podcast to discuss the benefits and challenges of using artificial in...[ Price : $8.95]
CDER posts a list of 10 things it says people should know about the Centers pharmaceutical quality function.[ Price : $8.95]
Medline Industries recalls (Class 1) its Medline Sub-G Endotracheal Tube with Subglottic Suctioning after complaints were received...[ Price : $8.95]
A bipartisan group of 11 Senate and House members asks FDA to require hearing aid labeling to disclose if the device uses propriet...[ Price : $8.95]
The International Council on Harmonization publishes the M12 final guideline on drug interactions and an accompanying question-and...