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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...

FDA General

Azar: I Have a Shocking Amount of Power, Intend to Use It

HHS secretary Alex Azar, a former top Lilly executive, vows to use his shocking amount of power to force drug prices down, mirroring objectives of FDA...

Federal Register

Draft Guide on Pediatric HIV Studies

Federal Register notice: FDA makes available a draft entitled Pediatric HIV Infection: Drug Development for Treatment.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 5/11/2018.

Federal Register

FDA Panel To Review Cordis PMA Adverse Events

Federal Register notice: FDAs Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews a Cordis PMA for the Incraft AAA Sten...

Federal Register

Guide on Outsourcing Facility Definition

Federal Register notice: FDA makes available a guidance entitled Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.