FDA Related News

Human Drugs

FDA Modifies REMS for Mifepristone

FDA modifies a Risk Evaluation and Mitigation Strategies program for mifepristone, a drug used in early abortion and miscarriage care.

Biologics

Administration Sidelining Vaccine Scientists: Ex-FDAers

Two former FDA scientists say it is a mistake for FDA and CDC to bypass advisory committees when making Covid vaccine decisions.

Medical Devices

Medical Device Integrity Act Introduced

Sens. Cassidy and Baldwin introduce bipartisan legislation to require medical device manufacturers to comply with FDA record requests to better prepar...

Human Drugs

FDA Updates Off-Patent, Off-Exclusivity List

FDA updates the list of off-patent and off-exclusivity drugs without an approved generic, adding some over-the-counter products.

Federal Register

Guide on Referencing Definition of Device

Federal Register notice: FDA makes available a draft guidance on Referencing the definition of device in public documents.

Federal Register

Traumatic Brain Injury Eye Assessor in Class 2

Federal Register notice: FDA classifies the traumatic brain injury eye movement assessment aid into medical device Class 2 (special controls).

Human Drugs

Biogen to File Alzheimers Confirmatory Trial Protocol

Biogen says it will submit a final clinical trial protocol to FDA 3/2022 for a required post-marketing trial of its controversial Alzheimers drug Aduh...

FDA Denies Petition on Eugia Pharma ANDA

FDA denies a petition questioning Eugia Pharmas use of an ANDA for a generic Makena autoinjector.

Human Drugs

Improve Cancer Checkpoint Inhibitor Development: Pazdur

Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver call for changes in the development process for new c...

Human Drugs

FTC Should Look Into Par Vasostrict Petition: FDA

FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a delaying tactic.