FDA approves an Allergan NDA for RhoFade (oxymetazoline hydrochloride) cream for the topical treatment of persistent facial erythema (redness) associa...
Federal Register Notice: FDA seeks comments on an information collection extension for its Adverse Event Program for Medical Devices (Medical Product ...
Departing FDA commissioner Robert Califf calls for stronger public/private efforts to end the countrys opioid abuse crisis.
Several stakeholders suggest that an FDA proposed rule on electronic submission of labeling for home-use medical devices is not needed.
CDER says it approved 22 novel drugs in CY 2016, lower than the average number of novel drug approvals.
Symbiomix files an NDA for Solosec (secnidazole oral granules) for treating bacterial vaginosis.
CBER releases a list of 14 guidances it expects to develop in this calendar year.
FDA says it has approved a Roxane Laboratories ANDA for the first generic version of Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution for tre...