FDA Related News

Human Drugs

Generic Drugs Not Covered by West Virginia Tort Law

A West Virginia appeals court says its state law does not allow liability of a branded drug company for an injury caused by a generic version of the d...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Product Quest MFG and Reine Lifescience.

Combo Product Proposed Rule Offers More Transparency

FDA posts a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process.

Federal Register

Info Collection on Drug Supply Chain Security Pilot

Federal Register notice: FDA submits for OMB approval a new proposed information collection entitled DSCSA Pilot Project Program.

Human Drugs

Bill Introduced to Punish Drug Firms Over Opioids

Rep. Tulsi Gabbard (D-HI) and senator Bernie Sanders (I-VT) introduce legislation to hold pharmaceutical companies accountable for profiting from Amer...

Human Drugs

Subcutaneous Actemra Approved by FDA

FDA approves a subcutaneous formulation of Genentechs Actemra (tocilizumab) for treating active polyarticular juvenile idiopathic arthritis in patient...

Federal Register

FDA Partial Withdrawal of OTC Monograph

Federal Register notice: FDA announces a partial withdrawal of a proposed rule published in the 8/21/2003 Federal Register that would have amended the...

Human Drugs

FDA Clears Baxter Spectrum IQ Infusion System

FDA clears a Baxter International 510(k) for the Spectrum IQ Infusion System with Dose IQ Safety Software.

Human Drugs

FDA Approves UCB Epilepsy Drug for Children

FDA approves a UCB supplemental NDA for Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in treating parti...

Medical Devices

Breakthrough Designation for Immunicom Cancer Device

FDA grants Immunicom a breakthrough device designation for its Immunopheresis therapy, which is based on a proprietary technology that selectively rem...