OMB Control Number: 0910-0929Expiration Date: 06/30/2027 The National Survey on Numerical Claims in Prescription Drug Advertising is designed to assess how adults interpret different claims used […]

[6-20-2024] The Food and Drug Administration is advising consumers not to purchase or use Infla-650, a product promoted and sold for pain on various websites, including www.nutraherbusa.com, […]

Recognized Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales M100 standard is recognized Haemophilus influenzae and parainfluenzae […]

Recognized Interpretive Criteria Additional FDA-Identified Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Haemophilus influenzaand parainfluenzae M100 standard […]

Submit Comments by 09/20/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Docket Number: FDA-2013-D-0710 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for […]

Looking for FDA-Recognized Susceptibility Test Interpretive Criteria? Looking for recent updates? Please see: Notices of Updates Sign up to receive FDA Recognized Antimicrobial STIC Breakpoints email […]

[6/20/2024] Today, FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching […]

Docket Number: FDA-2017-D-0154 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]