FDA Related News

Medical Devices

Guide on Manufacturing Site Change Supplements

FDA posts a guidance entitled Manufacturing Site Change Supplements: Content and Submission.

Medical Devices

EhmetDx Positioning Software Cleared

FDA clears an EhmetDx 510(k) for its 3D CBCT (cone beam computed tomography) positioning software to be used in patient treatment at the McLaren Proto...

Federal Register

Approval Withdrawn for 9 ANDAs

Federal Register notice: FDA withdraws approval of nine ANDAs from multiple applicants.

Federal Register

Drug GMP Data Integrity Guidance

Federal Register notice: FDA makes available a final guidance entitled Data Integrity and Compliance With Drug CGMP: Questions and Answers.

Human Drugs

Celltrion BLA for Herceptin Biosimilar

FDA approves a Celltrion BLA for Herzuma (trastuzumab-pkrb) as a biosimilar to Genentechs Herceptin (trastuzumab) for patients with HER2-overexpressin...

Human Drugs

Senate Bill Introduced to Curb High Drug Prices

Senators Richard Blumenthal (D-CT), Kamala Harris (D-CA), Jeff Merkley (D-OR), and Amy Klobuchar (D-MN) introduce the Curbing Unreasonable Rises and E...

FDA General

NEWSROOM CLOSED FOR THE HOLIDAYS

FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Wednesday, January 2, 2019.

FDA Equitable Remedy Authority in Doubt: Attorneys

Two Hyman, Phelps & McNamara attorneys question whether FDA has authority to seek equitable relief in cases involving violations of the Federal Food, ...

Medical Devices

More Benefit than Risk in Non-Device Software: FDA

FDA says there is more benefit than risk in non-medical device software digital health products.

Human Drugs

FDA Pulls Generic Drug Labeling Safety Update Rule

FDA commissioner Scott Gottlieb says FDA is withdrawing a proposed rule to allow generic drug companies to independently add new safety information to...