Drug Disposal: Drug Take Back Options The best way to safely dispose of most types of unused or expired medicines Medicine take back options are the […]

On This Page Date: December 4, 2024 Time: 8:00 AM – 3:00 PM ET Location: Event Location FDA HeadquartersFDA headquarters in White Oak, MD 10903 New […]

Minimum Inhibitory Concentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa ≤ 0.25 0.5 ≥ 1.0 ≥ 19 16-18 ≤ 15 […]

Action The U.S. Food and Drug Administration has approved Orlynvah (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused […]

Annual Reports on Inspections of EstablishmentsSection 705 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to publish annual reports on its website […]

Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex […]

Docket Number: FDA-1996-D-0405 Issued by: Guidance Issuing Office Office of Inspections and Investigations Compliance Policy Guide Sec. 110.100 was withdrawn November 4, 2021 Issued: 10/01/1980Revised: 04/14/2000Withdrawn: […]

Issued by: Guidance Issuing Office Office of Inspections and Investigations Compliance Policy Guide Guidance for FDA staff and Industry CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs Document Release Date: June 2, 2007 This document supersedes Compliance Policy Guide (CPG) “Sec. 130.300 FDA Access […]