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Human Drugs

Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement

The Federal Circuit Court of Appeals says promotional materials developed by Teva were enough to induce infringement of a GSK carvedilol patent despit...

Medical Devices

Captains Cloth Selling Unapproved KN95 Masks: FDA

FDA warns Captains Cloth it is marketing unapproved, adulterated, and misbranded KN95 face masks.

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...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include BBC Group, Lepu Medical Technology and Sanit Technologies.

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...