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

WASHINGTON -Employees of the U.S. Environmental Protection Agency recently placed on leave after signing a letter critical of ...

The U.S. Food and Drug Administration (FDA) on Thursday published more than 200 complete response letters ((CRLs)), through ...

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.

Experts question whether the agency possesses the authority to issue such letters. But ignoring an agency notice or request ...

The staff are among more than 130 federal employees facing investigation for signing a letter that EPA officials say misleads ...