News

Applied Clinical Trials Online58m
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...
Quality Assurance & Food Safety1h
FDA Calls for Streamlined Product Recall Communications to Protect Food for Infants and Children
The U.S. Food and Drug Administration is calling for increased attention to product recall communications from industry ...
FDA commissioner backs MAHA push to improve food safety
FDA Commissioner Dr. Marty Makary joins ‘Fox & Friends’ co-host Steve Doocy for a morning walk to discuss the agency’s focus ...
FDA funding clash looms between Senate, House
Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...
Stocktwits on MSN2h
FDA May Fast-Track New Drug Reviews In Return For Companies Lowering Drug Prices: Report
The U.S. Food and Drug Administration may reportedly fast-track new drugs from pharmaceutical companies that “equalize” the ...
FDA Offers to Trade Faster Drug Reviews for Lower US Prices
Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...
BioSpace3h
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
KFF Health News4h
FDA Posts 200 Letters Citing Initial Concerns About Approved Drugs
The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...
STAT4h
Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA mulls faster drug reviews in exchange for lower prices in U.S.- Bloomberg
FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...
Watch CNBC's full interview with FDA commissioner Dr. Marty Makary
Dr. Marty Makary, FDA commissioner, joins 'Squawk Box' to discuss what hindsight tells science about the best route to take ...