FDA Launches Effort to Accelerate Drug Trials ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

FDA issues final guidance on rare disease drug development The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural ...

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules ...

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” In conjunction with a ...

The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process. In an announcement in the Federal ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

The biotechnology company will use the federal pilot program for its planned $2 billion Saratoga Springs manufacturing campus ...