Attorneys from DLA Piper complain that a new final FDA guidance on Clinical Decision Support (CDS) Software appears to be more expansive in scope than...
Eugia U.S. (formerly AuroMedics Pharma) recalls one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a product complaint ab...
The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used in human clinical t...
FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.
FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol).
FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.
FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...
