Federal Register notice: FDA releases a list of 10 information collections that have been approved by OMB.
Federal Register notice: FDA submits to OMB an information collection extension for Bar Code Label Requirement for Human Drug and Biological Products....
Citing issues with the drugs Apotex India-made research active ingredient, FDA issues Biohaven Pharmaceutical Holding Co. a complete response letter o...
Becton Dickinson recalls its Alaris Pump Module Model 8100 bezel assembly because of a defect that could result in inaccurate fluid delivery to patien...
Vanda Pharmaceuticals receives FDA notification about undisclosed sNDA deficiencies with a supplemental NDA for Hetlioz (tasimelteon) for treating jet...
A new study in BMJ criticizes the strength of the data on which FDA based its 2017 approval of Otsuka Pharmaceuticals NDA for mental disorder-treating...
FDA posts a final guidance on Postmarketing Safety Reporting for Combination Products.