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

The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.

One of the major complaints levied against FDA by the current administration is that the approval process is too complicated, takes too long, and needs to be modernized. The new leadership pledged to ...

A new EastEnders guest star has revealed she was previously rejected by the soap 37 years ago. Shazia Mirza appears in today's episode of the BBC soap as Dr Ayub, who is involved in the baby Jimmy ...

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

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.

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 US Food and Drug Administration (FDA) has taken the radical move of publishing more than 200 decision letters, known as ...

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.

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...

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