fda rejection letters

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FDA publishes rejection letters sent to drugmakers

FDA Will Share Rejection Letters Drugmakers Often Conceal

The US Food and Drug Administration is starting to publish letters the agency sent to pharmaceutical companies when their drugs were rejected, detailing information that until now has mostly been hidden from investors and the public.

Reuters on MSN · 1d

US FDA publishes 200 rejection letters in transparency push

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work. The published letters were issued in response to marketing applications of certain drugs or therapies submitted to the FDA between 2020 and 2024.

Fierce Biotech · 23h

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. | The FDA has released an "initial batch" of more than 200 complete response letters (CRLs) in efforts to boost transparency.

Fierce Pharma31m

‘Weak evidence’ and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

17h

F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

BioSpace1h

Capricor Plunges on FDA Rejection of DMD Cell Therapy

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

STAT1d

Pharmalittle: We’re reading about Regeneron’s patent maneuvers, FDA rejection letters, and lots more

A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...

Indianapolis Business Journal23h

FDA begins sharing rejection letters drugmakers often kept secret

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.

BioSpace3h

FDA’s Rejections: We Read 200 CRLs So You Don’t Have To

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

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