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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 ...
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...
The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...
The U.S. Food and Drug Administration (FDA) on Thursday published more than 200 complete response letters ((CRLs)), through ...
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.