FDA issues two final orders reclassifying certain Hepatitis C virus diagnostic tests from Class 3 to Class 2.
Federal Register: FDA seeks comments on an information collection extension entitled Administrative Detention and Banned Medical Devices.
Federal Register notice: FDA corrects a 10/27 notice identifying the Web site where to find CDRHs fiscal year 2022 proposed guidance development.
FDA amends the emergency use authorizations for both the Moderna and Pfizer-BioNTech Covid-19 vaccines to allow a booster dose for all individuals 18 ...
CDRH says a recent journal article sheds some light on an agency safety alert about the risk of medication overdose from the moat area of ENFit LDT sy...
Former FDA chief counsel Stacy Cline Amin says the Covid-19 emergency has been the single greatest catalyst for advancing the use of real-world eviden...
FDA grants BioMarin accelerated approval for Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achond...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Jazz Pharmaceuticals Sunosi (solriamfetol Hcl)....