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

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

An unusually large number of overdoses sent crews searching alleys and homes for victims. Officials have not said what type ...

Doctors with special licenses no longer need to use special prescription pads that are difficult to obtain for their patients ...

I hope you can subscribe more than I worry about. Subscription is the best option for panic disorder," he quivered.Meanwhile, ...

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

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

A massive analysis recently published in the journal Aging Cell revealed that rapamycin — the immunosuppressant drug turned ...

An international study led by researchers at the University of Colorado Anschutz Medical Campus has identified a promising ...

These biomarkers developed through analysis of DNA methylation appear to be the first ones able to predict response to ...

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...