A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging ...

Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

The debate over vaccines back in the forefront, as, according to an internal memo, the FDA is reportedly planning to change ...

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

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 ...

The Government Accountability Office (GAO) is urging the U.S. Food and Drug Administration (FDA) to use the most stringent pre-market review process in approving high-risk medical devices, according ...

The FDA has released a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices, according to an FDA news release. The guidance is meant to ...