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

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

The lawsuit alleges that a decision in May to remove COVID-19 vaccines from the federal list of recommended vaccines for ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.

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 wave of menopause-related legislation has been introduced across the United States this year, leading to possible shifts in ...

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

On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and safety of COVID-19 vaccines for young children.

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...