For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...

The Food and Drug Administration is seeking to develop a database of de-identified electronic medical records to help the agency better track adverse drug effects. Currently, adverse drug event ...

Lower-income countries rarely gain timely access to FDA-approved drugs tested in their populations, highlighting major global and ethical disparities. Physical access was defined as where a tested ...

FDA Commissioner Marty Makary has an ambitious plan to overhaul how quickly patients can access drugs in the US, but also wants to reduce reliance on pharmaceuticals by shifting the focus of research ...