The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

While many in the biotechnology sector expressed excitement for faster drug approval timelines, some researchers voiced ...

The FDA declined to endorse leucovorin as a treatment for autism, but approved the drug to treat cerebral folate deficiency, ...

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label ...

(CNN) — A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug ...