FDA

Competition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices.

The FDA's registry exemption program makes key death data about heart devices inaccessible and can take up to two years...

The administration points to statutory language, including definitions amended by the ACA, as preventing that FDA from allowing states to...

Stakeholders will have the next 75 days to comment on the proposed rule, which largely follows an outline HHS provided...

For nearly two decades, malfunctions and injuries linked to more than 100 medical devices were funneled into an FDA database...

The administration set a record in fiscal year 2017, beat it in fiscal year 2018, then beat it again in...

Factors that the ECRI Institute considers in developing the medical technology hazard list include severity of risk, frequency of harm,...

Nationwide, drug shortages of all kinds ? from antibiotics to heart drugs to saline solution ? are increasing and having...

The ruling is likely to be challenged at the United States Court of Appeals for the District of Columbia Circuit.

The FDA has released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices.

Spravato maker Janssen provided the FDA modest evidence that it worked and only in limited trials. It presented no information...

Agency seeks input on possible approaches to discourage high-dose prescribing.