FDA Related News

Human Drugs

CGMP Violations Found at Claris Injectables

FDA warns Baxters Claris Injectables about CGMP violations in its production of finished pharmaceuticals at its India facility.

FDA Inclusion/Exclusion Criteria Workshop

FDA releases a summary of points covered at a 4/16 workshop on clinical trial inclusion and exclusion criteria.

Human Drugs

FDA Clears Vallum Nanotechnology PEEK Spinal Fusion Device

FDA clears a Vallum Corp. 510(k) to market a polyetheretherketone spinal interbody fusion device with a PEEKplus nanotextured surface created by the c...

Medical Devices

PMA Filed for Obesity Device

BAROnova files a PMA for the TransPyloric Shuttle device intended for treating obesity.

Human Drugs

Breakthrough Therapy Evidence Misconceptions

A Yale School of Medicine research study says that doctors and their patients may not fully understand the level of evidence involved in approval of a...

Medical Devices

Biliary Stent 510(k) Submission Guidance

FDA issues a draft guidance on 510(k) submissions for metal expandable biliary stents.

FDA Extends Review of Invokana Supplemental NDA

FDA extends by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the...

Medical Devices

Stryker Gains Approval for Surpass Streamline Flow Diverter

FDA approves a Stryker PMA for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms.

Human Drugs

Firms Recall Valsartan-containing Products Due to Impurity

FDA says several companies have recalled their valsartan-containing drug products, which are used to treat high blood pressure and heart failure, due ...

Medical Devices

FDA Clears Quidels Solana Bordetella Assay

FDA clears a Quidel Corp. 510(k) for the Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnosti...