A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.

The FDA Center for Tobacco Products is utilizing a real-time communication process to decrease application review times.

And FDA explains that they don’t have any extra. Congress has been underfunding FDA for decades, and the agency only stays afloat now by virtue of user fees the industry pays to get submissions ...

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

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 ...

On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National ...

The US pharmaceutical industry has told the US Food and Drug Administration (FDA) that using process models alone is sufficient for assessing batch uniformity in advanced manufacturing. They believe ...

The Food and Drug Administration recently announced that, for the first time in more than 20 years, it will expand the range of permitted sunscreen options available to consumers this summer. This ...

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...