FDA’s focus on playing a direct role in lowering drug prices may provide opportunities for some pharmaceutical companies to seek a regulatory advantage. But it also places enormous pressure on ...

The FDA rarely, if ever, releases the data it uses to approve a generic medication. As a result, physicians, pharmacists, ...

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 ...

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 ...

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 ...

Generic drugs account for more than 90 percent of prescriptions filled in the United States. The FDA insists that they “have the same high quality, strength, purity and stability as brand-name drugs.” ...

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 most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But ...

This is read by an automated voice. Please report any issues or inconsistencies here. See more from the L.A. Times in Google Search. Set us as preferred A rare-disease patient questions what drives ...

A new draft guidance document released by the US Food and Drug Administration (FDA) on 24 July 2013 concerns so-called Pre-Launch Activities Importation Requests (PLAIRs),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