Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem cell clinics.
FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.
FDA extends by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Janssens Zytiga (abira...
OMB approves seven information collections that include humanitarian-use devices, Right-to-Try Act reporting, and positron emission tomography drug GM...
Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.
Federal Register notice: FDA sends to OMB an information collection extension entitled Conflict-of-Interest Information for Participation in Food and ...
A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from political interference during health em...
