Background The Federal Food, Drug, and Cosmetic Act (FD&C Act), section 524, authorizes FDA to award priority review vouchers (PRVs) to sponsors of approved tropical disease […]
NEW YORK (Reuters) – About one-third of U.S. employer health plans are offering coverage of GLP-1 drugs for both diabetes management and weight loss, up from […]
Share on PinterestThe U.S Supreme Court voted in favor of preserving access to the FDA-approved mifepristone. Geoff Livingston/Getty Images On June 13, the U.S. Supreme Court […]
FDA’s Compounding Quality Center of Excellence created small stakeholder group to discuss issues that affect outsourcing facilities, health care providers that purchase their products and industry […]
FDA’s Compounding Quality Center of Excellence supports building networks and fostering a culture of quality within the industry. Supporting Outsourcing Facilities Outsourcing facilities that participate in […]
Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales M100 standard is recognized Pseudomonas aeruginosa M100 standard is recognized […]
What is FDA’s role in regulating drugs? We oversee prescription, generic, biosimilars, and over-the-counter drugs. But what is our role when it comes to drug regulation? […]
(Reuters) -The U.S. Supreme Court’s ruling on Thursday keeping the abortion drug mifepristone on the market with no new restrictions ends one chapter of the legal […]
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