U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services.

Less regulation was also the focus of committee chair Rep. James Comer (R-Ky.). "The Biden administration stifled innovation ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

Weeks after ordering Food and Drug Administration employees back into the office, the agency is reversing course, allowing ...

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

The Food and Drug Administration has gutted a division responsible for training agency staff and outside health-care ...

A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical ...

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

A U.S. district judge foiled the Food and Drug Administration's plan put forth under the Biden administration to regulate lab ...

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to ...