Federal Register notice: FDA announces a 3/27 Pulmonary-Allergy Drugs Advisory Committee meeting. to discuss a AllerQuest NDA for Pre-Pen Plus, a skin...
Stakeholders give FDA comments on two coronary drug-eluting stent guidances
Retired CDRH branch chief Morris Waxler, who approved the original LASIK vision correction indication, urges the Center to stop deceiving the public a...
Stakeholders comment on an FDA 2018 public meeting on drug shortage causes and solutions.
FDA extends its review of a Nuvectra PMA for its Virtis Sacral Neuromodulation system, indicated for use in treating chronic urinary retention and sym...
FDA clears a XableCath 510(k) for its Peripheral Crossing Catheters, intended for use to cross challenging lesions in both arterial chronic total occl...
FDA approves Mylans application for the first generic form of GlaxoSmithKlines Advair Diskus asthma inhalation powder.
FDA posts a draft guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.