A new report estimates speeding up FDA drug approvals by one year could generate over $10 trillion in economic value from ...

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 ...

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 ...

Getting prescription drugs to market faster is a major priority for the Food and Drug Administration, its commissioner said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum in ...

This is read by an automated voice. Please report any issues or inconsistencies here. A rare-disease patient questions what drives research costs behind $41,000-per-month medication, even before FDA ...

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 ...

Researchers urge inclusion of negative studies on drug labels ...

A new draft guidance document released by the US Food and Drug Administration (FDA) on 24 July 2013 concerns so-called Pre-Launch Activities Importation Requests (PLAIRs),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