News

STAT1h
Questions about the FDA’s ‘radical transparency’ efforts
Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...
STAT19h
NIH grant cuts, FDA transparency questions, and biotech M&A
On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...
Fierce Biotech23h
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
BioSpace11d
FDA’s AI Rollout Raises Questions Around Readiness, Legality
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
The Hidden Power Of Questions In The Age Of AI
As AI becomes central, the ability to ask the right question isn’t just a technical skill but a foundational one.
FDA vaccine official restricted COVID vaccine approvals against agency advice
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
Science-Based Medicine22hOpinion
Go Ahead, Make the Case That Science, Free Speech, and the FDA Are Thriving Under Drs. Marty Makary and Vinay Prasad
Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...
Scotland faces up to its drug crisis by offering the UK’s first supervised injection facility
In a quiet corner of Glasgow’s East End, a radical public health experiment is underway. For the first time in the United Kingdom, people who inject illicit drugs such as heroin and cocaine can do so ...
Even low doses of CBD may cause harm to the liver in some people, FDA study finds
An FDA-funded clinical trial found even modest CBD use triggered elevated liver enzymes in some healthy adults, raising ...
MedPage Today14d
Experts Have Questions About FDA's New Priority Review Program
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers about the FDA's new national priority voucher program, experts told ...