STAT

What’s FDA plotting for therapy chatbot regulation?

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting ...

Dr. Oz and FDA chief say biosimilar drug reform will lower prices

Trump administration officials pledged Monday that major reforms for biosimilar drug approvals will expand access and lower ...
India West

FDA Taps Vaxxer Skeptic Vinay Prasad To Oversee Vaccine, Gene Therapy Regulations

WASHINGTON, D.C. — In a move that has already rattled Wall Street and divided the medical community, the U.S. Food and Drug Administration has appointed Dr. Vinay Prasad—an oncologist, outspoken ...
MedPage Today

FDA 'Expert Panels' Raise Concerns of Evading Regulations, Ethics

Bypassing its standard pathways for scientific discussions, FDA has recently held a slew of so-called "expert panels" that sidestep legal procedures and ethics guardrails, raising concern about cherry ...
New York Post

With Operation Warp Speed II, Trump can slash red tape — and save lives

The Food and Drug Administration aims to let only safe and effective drugs reach the US market — but its turtle-speed approval process may be killing more patients than it protects. FDA regulations ...
STAT

Inside FDA, career staffers describe how political pressure is influencing their work

Lizzy Lawrence spoke with more than 20 current and former FDA staff, interviewed legal experts, and reviewed agency documents to report this story. Lizzy Lawrence leads STAT’s coverage of the Food and ...
The New York Times

Drug Smugglers Change Supply Routes to Evade U.S. Warships

With the United States surging its military presence in the region and bombing boats, countries in the Caribbean are seeing more flights carrying illegal drugs. By Frances Robles Reporting from ...
The Hill

GOP senators urge RFK Jr. to crack down on medication abortion

Almost every Senate Republican on Thursday urged the Food and Drug Administration (FDA) to “reevaluate” whether a newly approved generic version of the abortion drug mifepristone should stay on the ...
FiercePharma

FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing

Against a backdrop of tariff updates and a drug pricing deal from the Trump administration, the FDA charted a pair of moves this week in its push to make drug manufacturing more attractive in the U.S.
UPI

FDA approves a second generic abortion pill despite opposition

Oct. 3 (UPI) --The Trump administration this week approved a second generic abortion pill despite opposition from Republicans and anti-abortionists. The Food and Drug Administration approved the ...
Yahoo

Drug discount program regulations in RI go into effect after judge denies big pharma suit

A new law regulating a federal drug discount program in Rhode Island went into effect on Wednesday, Oct. 1, after a District Court judge denied a preliminary injunction requested by a pharmaceutical ...
WPBF

New FDA regulations inform women about breast density in Boca Raton

OCTOBER, WHICH ALSO MEANS THE BEGINNING OF BREAST CANCER AWARENESS MONTH. AND AS PART OF OUR COMMITMENT TO YOU, WPBF 25 NEWS WILL AIR STORIES ON BREAST CANCER EVERY WEDNESDAY DURING OCTOBER. YOU CAN ...