FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
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.

Human Drugs

Trump Plan Wants Pricing Disclosed in DTC Ads

President Trumps blueprint for lowering prescription drug prices orders FDA to require drug companies advertising their drugs to include pricing infor...

Human Drugs

Novartis Expanded Approval for MS Drug in Children

FDA expands approval of Novartis Gilenya (fingolimod) to treat relapsing multiple sclerosis in children and adolescents.

Medical Devices

Vyaire Medical Recalls AirLife Resuscitation Devices

Vyaire Medical recalls its AirLife resuscitation devices and Broselow convenience kits due to risk of a malfunction caused by an error in the products...

Medical Devices

Patient and Industry Groups Seek Diagnostics Reforms

A group of patient and industry organizations write Congressional leaders urging them to enact legislation to modernize the statutory oversight of cli...

Federal Register

Comments Sought on Biologic Samples Requests

Federal Register notice: FDA seeks comments on an information collection extension for Request for Samples and Protocols (OMB Control Number 09100206)...