November 13, 2024
TOPLINE: Exposure to particulate matter measuring less than 2.5 µm (PM2.5) is associated with an increased incidence of head and neck cancer (HNC), with the strongest […]
November 13, 2024
TOPLINE: Cardiac arrest survivors with complete neurologic recovery at hospital discharge show significantly improved long-term survival rates, found a study. METHODOLOGY: Researchers analyzed data from four […]
November 13, 2024
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 […]
November 12, 2024
Share on PinterestNew research finds that taking a daily vitamin D supplement may help lower blood pressure, especially for older adults with obesity. Tatjana Zlatkovic/Stocksy United […]
November 12, 2024
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 […]
November 12, 2024
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 […]
November 12, 2024
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 […]
November 12, 2024
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 […]
November 12, 2024
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 […]
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