STAT

FDA broadens search for new top drug regulator after early setbacks

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.
The Associated Press

Nearly 2,000 drug plants are overdue for FDA checks after COVID delays, AP finds

Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in ...
CNN

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
FiercePharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...
The Washington Post

Top FDA drug regulator raises alarms about expediting approvals

The newly installed top U.S. drug regulator has raised concerns about the legality and pace of initiatives to expedite drug decisions, arguing they could threaten Americans’ safety, according to three ...
STAT

FDA review of drugs is slowing while application delays are growing, analysis finds

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter ...
CNN

FDA moves to fast-track review of psilocybin and methylone for mental health

Some psychedelic drugs, once considered fringe, are getting a step closer to possibly being approved for use as mental health treatments in the United States. The US Food and Drug Administration on ...