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Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.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...
Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Presentations in Presc...
Federal Register notice: FDA issues an order debarring David J. Kempema for five years from importing or offering for import any drug into the U.S.
Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufacturing regulation wi...
AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.
