HHS lists drug and medical device regulatory priorities for FDA.
FDA clears a Gel-e Inc. 510(k) for its adhesive bandage for prescription and over-the-counter use in managing moderately to heavily exuding chronic wo...
FDA accepts a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor...
FDA commissioner Scott Gottlieb lays out regulatory priorities for 2018 for drugs and medical devices.
FDA opens a Web site to give doctors antibiotic breakpoint information in a more efficient and timely way.
FDA releases the FDA-483 with 10 observations from an inspection at Indias Shilpa Medicare Limited.
FDA issues a guidance on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial an...
Federal Register notice: FDA sends to OMB an information collection extension request for Data To Support Drug Product Communications as Used by FDA: ...