FDA Related News

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.

Human Drugs

Changes Asked in Targeted Therapies Guidance

Four stakeholders ask for changes to an FDA draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease.

Human Drugs

2nd FDA Rejection for Apricus ED Drug

FDA sends a second complete response letter to Apricus Biosciences on its NDA for Vitaros (alprostadil topical cream) for treating erectile dysfunctio...

Human Drugs

Parkinsons NDA for Parkinsons Accepted for Review

FDA accepts for review an Acorda Therapeutics NDA for Inbrija (inhaled levodopa) for treating symptoms of Off periods in people with Parkinsons diseas...

Federal Register

Final Rule on Device Trials Conducted Outside U.S.

Federal Register final rule: FDA amends its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S....