The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part of the Congressional...more
On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs...more
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more