With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

A revamped plan to streamline the FDA’s guidance practices stands to be tested as President-elect Donald Trump looks to ...

A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...

There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared ...

In early December, the Supreme Court heard oral argument in Food and Drug Administration v. Wages and White Lion Investments, a challenge to the FDA's ...

Dietary supplements — vitamins, minerals, botanicals and probiotics — are more popular than ever. Do they make a difference?

The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain.

A new law that took effect on Jan. 1 regulates some practices of PBMs, which act as middlemen between drug manufacturers, ...

In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, ...

Mumbai: The Food and Drug Administration (FDA) conducted surprise inspections of hotels and restaurants in December, issuing ...

It specifies that by 2035, China expects to fully ensure the safety, efficacy, and accessibility of drugs and medical devices ...