FDA Related News

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 ...

Federal Register

OMB Approves 4 Information Collections

Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.

Human Drugs

CGMP Violations at BBC Group

FDA warns Chinas BBC Group about CGMP violations in its production of finished pharmaceuticals, along with unapproved new drug and misbranding issues....

Human Drugs

Inspection Finds CGMP Issue at Sanit Technologies

FDA warns Sanit Technologies about CGMP violations in its production of finished drugs.

Biologics

Stem Cell Therapy Firm Marketing Unapproved Cellular Products

FDA cautions Stem Cell Therapy of Las Vegas that it is marketing unapproved cellular products and exosomes.

Medical Devices

FDA Clears Surround Medical Systems Dental Imaging

FDA clears a Surround Medical Systems 510(k) for its Portray dental imaging system, a 2D diagnostic tool that allows 3D tomosynthetic and 2D synthetic...