An FDA advisory committee recommends that FDA should develop standards for device companies to use when any cybersecurity concern is communicated to p...
Federal Register notice: FDA makes available 53 product-specific guidances (PSGs) 34 new guidances and 19 revised ones.
FDA awards three grants under a pilot program to support developing publicly available clinical outcome assessments and related endpoints for specific...
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Siemens Healthcare Diagnostics for the Advia Centaur Zika test.
FDA principal deputy commissioner Amy Abernathy says the agency will announce within a month a plan to modernize its information technology approach f...
Janssen Pharmaceutical files a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthritis.
FDA posts a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspection of the drug out...
Federal Register notice: FDA seeks comments on a petition requesting exemption from the premarket notification requirements for powered wheeled stretc...