Submit Comments by 01/14/2025 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-2016-D-1307 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]

Docket Number: FDA-2016-D-2285 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for […]

FDA has reevaluated data supporting cefiderocol breakpoints against Stenotrophomonas maltophilia. The review included data submitted to FDA under the cefiderocol new drug application, published literature, and […]

FDA Identified Breakpoints Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameters in mm) Pathogen S I R S I R Enterobacteralesa,b M-100 standard is recognized Pseudomonas […]

What’s New What is the CDER Quality Standards Program? The CDER Quality Standards Program will help promote innovation in pharmaceutical development and manufacturing and streamline the […]

Delivery Method: VIA UPS Reference #: 320-25-13 Product: Drugs Recipient: Recipient Name Mr. Jinyan Wang Recipient Title General Manager Zhejiang Qimei Cosmetics Co., Ltd. No. 518 […]

Delivery Method: VIA UPS Reference #: 320-25-10 Product: Drugs Recipient: Recipient Name Mr. Alexis Wolkowinski Recipient Title President Multaler et Cie SAS 1 Rue Ambroise CroizatArgenteuil95100 […]