FDA Related News

Medical Devices

Ables Mach Screw Clip Cleared by FDA

FDA clears an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device.

Medical Devices

Single-use ENT Scope Cleared for Use

FDA clears a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat Scope.

Human Drugs

Lantern Orphan Status for Pancreatic Cancer Drug

FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer.

Federal Register

Panel to Discuss Cook Pediatric Esophageal Device

Federal Register notice: FDA announces a 9/17 Pediatric Advisory Committee to discuss a pediatric-focused safety review of Cook Medicals Flourish, an ...

Federal Register

Docket on Pediatric Product Safety Reviews

Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of product...

Human Drugs

KVK Tech Recalls Pneumonia Antibiotic

KVK Tech recalls two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the product.

Biologics

FDA Accepts 2 Keytruda sBLAs for Review

FDA accepts for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda (pembrolizumab) one for patients with renal cell carcinoma and ...

Medical Devices

Lepu Medical Technology Selling Unapproved Covid Tests: FDA

FDA warns Chinas Lepu Medical Technology it is marketing unapproved Covid-19 test kits in the U.S.

Intended Use Guidance Disappoints Stakeholders: Analysis

Attorney Patricia Kaufman says many stakeholders will be disappointed by the approach FDA has taken in its new intended use final rule.

Medical Devices

Boston Scientific Exalt Bronchoscope Cleared

FDA clears a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care ...