Background The Federal Food, Drug, and Cosmetic Act (FD&C Act), section 524, authorizes FDA to award priority review vouchers (PRVs) to sponsors of approved tropical disease […]

Image Español At the U.S. Food and Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best […]

FDA’s Compounding Quality Center of Excellence created small stakeholder group to discuss issues that affect outsourcing facilities, health care providers that purchase their products and industry […]

FDA’s Compounding Quality Center of Excellence supports building networks and fostering a culture of quality within the industry. Supporting Outsourcing Facilities Outsourcing facilities that participate in […]

  Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales M100 standard is recognized Pseudomonas aeruginosa M100 standard is recognized […]

What is FDA’s role in regulating drugs? We oversee prescription, generic, biosimilars, and over-the-counter drugs. But what is our role when it comes to drug regulation?  […]

Speech by Robert M. Califf, M.D., MACC Namandjé N. Bumpus Principal Deputy Commissioner – Office of the Commissioner (Remarks as prepared for delivery) I’d like to […]

Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]