FD&C Act 1938

Unapproved obesity drug retatrutide is fueling a fast-growing black market of counterfeit products, exposing gaps in the regulatory system as federal agencies struggle to keep up.

The US Food and Drug Administration has issued a proposed rule to classify medical device accessories separately, aiming to clarify regulatory oversight.

Split ruling reinstates DOJ subpoena to gender‑affirming care provider, finding the administration may pursue investigations consistent with its policy agenda.

A series of FDA warning letters flagged several injectable keratin hair‑straightening products for lacking required authorization.

Both stakeholders say that AI should support clinical workflows and that clinicians should maintain decision-making authority.

According to the regulator, ExThera Medical sent its Seraph 100 blood filters to a hospital for emergency/compassionate use without first obtaining permission.

The federal regulator contends the four biologics firms lack appropriate testing and marketing authorization.

According to new guidance, certain devices and software that track metrics such as heart rate and activity level will require less rigorous pre-market reviewal.