For Immediate Release: July 05, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Wednesday, […]

In fiscal year 2022, FDA’s Office of Orphan Products Development (OOPD) funded three natural history studies under the Orphan Products Grants program which serve to meet […]

Submit Comments by 09/03/2024 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 […]

[2/1/2019] FDA is warning compounders not to use glutathione-L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported […]

Online Advisory Letter Reference #683577   May 23, 2024 Upper Echelon Empire Beauty & Health Co.1350 N Chestnut StWinston Salem, NC [email protected] To Whom It May […]

Brian Green, DO, MS, FAADExpertise: Dermatology and Pediatric DermatologyTerm: 09/01/2021 – 08/31/2025Associate Professor, DermatologyMedical Director, TeledermatologyPenn State Health Milton S. Hershey MedicalCenter, Department of Dermatology500 University […]

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord […]

The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as […]

A change to the law will impact compounding of certain products beginning on March 23, 2020. On that date, biological products that were approved under the […]