FDA warns Spectrum Laboratory Products about CGMP and other violations in its production of API.
PhRMA says participation in a 4/29 meeting on incorporating patient experience in drug development for rare diseases shows the need for FDA to have a ...
CDER health science policy analyst Lauren Milner explains in a Webinar the reasons for and use of a new draft guidance on submitting documents using r...
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.
Eli Lilly says data from its REWIND study, a cardiovascular outcomes trial involving diabetes drug Trulicity (dulaglutide), showed a significant 12% r...
Federal Register notice: FDA determines that Johnson & Johnsons Nizoral (ketoconazole) topical cream 2% was not withdrawn from sale for safety or effe...
Federal Register notice: FDA is seeking comments on an information collection extension entitled Investigational Device Exemptions Reports and Records...
Stakeholders comment on an FDA discussion paper on artificial intelligence and machine learning as part of medical device software.