Federal Register notice: FDA sends a proposed collection of information to OMB for review and clearance Transfer of a Premarket Notification.
FDA alerts healthcare providers to the potential for increased image artifact or image voids associated with magnetic resonance angiography imaging fo...
FDA Review posts the Federal Register notices for the week ending 3/9/2018.
Federal Register notice: FDA determines that Mayne Pharma Internationals Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not wit...
FDA issues Warning Letters to all three duodenoscope manufacturers for failing to comply with a 2015 agency order to conduct postmarket surveillance s...
Federal Register notice: FDA makes available a draft guidance entitled Proprietary Names for New Animal Drugs.
FDA approves two ANDAs from Cipla Limited and Aurobindo Pharma for the first generic versions of Amgens Sensipar (cinacalcet hydrochloride) tablets fo...