Federal Register notice: FDA announces that it will adopt the current version of the Geopolitical Entities, Names, and Codes (GENC) Standard on 12/17/...
CDERs Office of Prescription Drug Promotion (OPDP) proposes research to determine how physician perceptions are influenced by drug marketing.
FDA approves a Celgene NDA for Otezla (apremilast) 30 mg twice daily for treating adult patients with oral ulcers associated with Behcets Disease.
FDA releases a final guidance on submitting next generation sequencing data to the Division of Antiviral Products.
FDA clears an Erchonia 510(k) to market FX low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.
FDA announces a 10/31 ICH Global Meeting on E8 Guideline on General Considerations for Clinical Trials to discuss a planned revision to the document....
Becton Dickinson recalls its Alaris Infusion Sets due to the potential for faster than expected delivery of medication (over-infusion) or an unintende...
Federal Register notice: FDA seeks an information collection extension on its guidance on emergency use authorizations.