The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

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

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

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

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

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

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

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 ...

While analysis of 18 identified biomarkers for adalimumab (Humira) initially yielded an AUC of 0.86 (95% CI 0.58-0.97), the ...

More than two dozen suspected drug overdoses in West Baltimore on Thursday got the attention of state and city leaders.