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

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 ...

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

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

The cover letter is more important than ever. In a world where AI can polish grammar and formatting, I use the cover letter ...

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 ...

This letter develops an iterative selection of training samples to extend ICEM with two versions: iterative fixed training sampling constrained energy minimization (CEM) (IFTS-CEM) which uses a fixed ...