Antimicrobial Regulatory Science Research Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]

Recognized Interpretive Criteria FDA Identified Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S SDDa I R S SDDa I R Enterobacteralesb ≤8/4 – […]

FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Pseudomonas aeruginosa” (MR15, January 2024), submitted by the Clinical and Laboratory Standards Institute […]

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 […]