FDA Related News

Indefinite Delay for Intended Use Rule

FDA delays indefinitely a final rule that would determine a medical products intended use based on the totality of the evidence.

Federal Register

Comments Sought on Professional Rx Promotion

Federal Register notice: FDA seeks comments on a proposed collection of information Health Care Professional Survey of Professional Prescription Drug...

Federal Register

FDA Exempts OTC Denture Repair Kits

Federal Register notice: FDA issues an order exempting from premarket notification (510(k) requirements over-the-counter denture repair kits.

Human Drugs

Advisors to Consider Lillys Baricitinib

FDA says a 4/23 Arthritis Advisory Committee meeting will consider a Lilly NDA for baricitinib tablets.

Human Drugs

Breakthrough Designation for Janssen Cancer Drug

FDA grants Breakthrough Therapy designation to Janssens erdafitinib for treating advanced urothelial cancer in adults.

Medical Devices

FDA Clears Royal Philips Radiography-Fluoroscopy System

FDA clears a Royal Philips 510(k) for is ProxiDiagnost N90, a digital radiography-fluoroscopy system.

Medical Devices

DxNow Clearance for ZyMot Sperm Devices

FDA gives 510(k) clearance to DxNow for its ZyMot ICSI and ZyMot Multi Sperm Separation devices.

Human Drugs

Duchenne Trial on Clinical Hold

FDA places a Solid Biosciences IGNITE DMD clinical trial for Duchenne Muscular Dystrophy on hold.

Human Drugs

United Pharmacy GAC Degrading Early: FDA

FDA says its tests show that glutamine in a United Pharmacy glutamine, arginine, and carnitine product degraded before its expiration date.

Human Drugs

Drug Industry Settlements Remain Low

A Public Citizen report says that federal criminal penalties against drug companies have fallen precipitously.