Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...

A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...

Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a ...

Duke patients in a new study prefer patient portal messages written using artificial intelligence — until they learn AI wrote ...

An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.

Christopher Ridley, a spokesperson for Moderna, said the state legislative efforts are largely a product of ...

Three U.S. senators are calling on Robert Kennedy Jr. to disclose what he and President Trump discussed with drugmakers ...

The employees returned Monday. An industry source with knowledge of the matter said “most, if not all of the CDRH people are being asked back.” One of the CDRH employees said people on their team who ...

The CDRH had a total of 2,230 employees as of 2023. Annual reports describing the number of employees in 2024 and previous years were recently removed from the FDA’s website.

Orthopedic surgery is a marvelous field because we can make meaningful improvements in the comfort and function of patients ...

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired ...