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FDA posts a draft guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.
Natures Rx recalls its Silver Bullet 10x product because it was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra ...
FDA issues a guidance to help medically necessary drug product manufacturers develop contingency plans for when manufacturing facilities are hit by hi...
A Healthcare and Public Health Sector Coordinating Council working group releases a Joint Security Plan with recommendations to address cybersecurity ...