FDA Related News

Human Drugs

Revised Biosimilar Research Roadmap Out

FDA releases a revised biosimilar research roadmap to help researchers develop proposals for funding under BsUFA 3.

Hearing on FDA Foreign Inspections

The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee schedules a 2/6 hearing on shortcomings in the FDA foreign...

Biologics

Biogen Abandoning Aduhelm in Alzheimers Re-focus

Biogen discontinues the further development and commercialization of controversial Alzheimers drug Aduhelm (aducanumab-avwa) as part of a move to repr...

Biologics

CBER Plans 9 Additional Guidances in 2024

CBER releases its guidance agenda for 2024 that includes a listing of topics upcoming guidances will address.

Human Drugs

Warning on Copycat Bausch Eye Drops

FDA issues a warning on South Moon and Rebright or FivFivGo eye drops because of potential risks for eye infections.

Clinical Study Diversity Workshop Comments

The stakeholder trade associations praise FDA for its 11/2023 workshop on enhancing clinical trial diversity and offer additional general and specific...

Medical Devices

GE Recalls Ventilator Air Compressors

GE Healthcares Datex-Ohmeda unit recalls its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says it became a...

Medical Devices

Maquet Cardiovascular Recalls Chest Drain

Maquet Cardiovascular recalls its Atrium Express Dry Suction Dry Seal Chest Drain in response to a related components recall by another company due to...

Human Drugs

Congressional Dems Ask SCOTUS Mifepristone Reversal

More than 260 congressional Democrats ask the Supreme Court to reverse lower court rulings restricting the use of the medical abortion drug mifepristo...

Medical Devices

Respironics Reports 111 Deaths in 3Q 2023: FDA

Just two days after agreeing to a consent decree, FDA says that Philips Respironics reported over 7,000 medical device reports and 111 death reports f...