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

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed foods are often targeted toward children and said the agency has focused on ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

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

FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...

Synchrony Medical announced that it received FDA 510 (k) clearance for its LibAirty airway clearance system.

Fully cell-free process aims to democratize personalized cancer therapeutics with shorter turnaround and negligible bioburden ...

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 ...