The FDA should require negative studies of a new drug to be included in the product's labeling -- not just those studies with ...

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 ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

Prior authorization is a standard process used by insurance companies to assess the safety, cost-effectiveness, and medical necessity of certain treatments. Certain medications, especially those on ...

A new draft guidance document released by the US Food and Drug Administration (FDA) on 24 July 2013 concerns so-called Pre-Launch Activities Importation Requests (PLAIRs), requests to FDA to allow the ...

(Yicai) June 22 -- CARsgen Therapeutics Holdings has entered the final stage of China’s marketing approval process and could ...