Recognized Interpretive Criteria Exceptions to the recognized standard of CLSI M100 Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales […]

Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element […]

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 […]

Bringing more drug competition to the market is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. In 2017, […]

By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of […]

The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize […]

For Immediate Release: March 21, 2024 Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) […]

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 […]

On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of […]