News

STAT12h
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 Biotech17h
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. | ...
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
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 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 ...
Science-Based Medicine16hOpinion
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 ...
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
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 ...
Chocolate Recall Update as FDA Sets Risk Warning
Meijer Inc. announced a recall of thousands of cases of Frederik's Dark Chocolate Almonds on June 13 due to the possible ...
Gene-edited pigs may soon enter the Canadian market, but questions about their impact remain
The Canadian government is currently considering approving the entry of gene-edited pigs into the food system.