FDA Related News

Federal Register

Medical Device Labeling Information Collection Extension

Federal Register notice: FDA seeks comments on an information collection exetension for Medical Device Labeling Regulations 21 CFR parts 800, 801, an...

Human Drugs

Medicines360 sNDA for Expanded Contraception Under Review

FDA accepts for review a Medicines360 supplemental NDA that seeks to extend the duration of use for preventing pregnancy from up to four years to up t...

Medical Devices

FDA Clears Access Vascular Central Catheter

FDA clears an Access Vascular 510(k) for the HydroPICC, a peripherally inserted central catheter, intended for long-term use.

Federal Register

Panel to Review Cannabidiol NDA

Federal Register notice: FDA announces a 4/19 Peripheral and Central Nervous System Drugs Advisory Committee meeting.

Human Drugs

FDA Accepts for Filing Liletta sNDA

FDA has accepted for filing a Medicines360 sNDA to increase the duration of use to prevent pregnancy of its Liletta hormone-releasing intrauterine sys...

Sharp Disagreement on DRD Pathway

PhRMA strongly opposes and AdvaMed strongly supports an FDA proposal for a devices referencing drugs regulatory pathway.

Human Drugs

PDUFA 6 Info Technology Goals and Progress

FDA posts a Web page linking to documents on its efforts to improve the predictability and consistency of the electronic submission process.

Medical Devices

Neotract Gains Expanded Clearance for UroLift System

FDA clears a NeoTract 510(k) for new indications for the UroLift System to treat an enlarged prostate or benign prostatic hyperplasia.

Medical Devices

Corindus Robotic Device Cleared for Vascular Surgery

FDA clears a Corindus Vascular Robotics 510(k) for the CorPath GRX System and its use in peripheral vascular interventions.

Human Drugs

FDA Says Divinity Products Destroys Kratom Supply

FDA says Divinity Products has recalled and destroyed dietary supplements it manufactured and distributed that contain kratom.