FDA U-turns on rare disease treatment: what it means for patients

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

New FDA approval process promotes development of rare disease gene therapies

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 ...
Psychiatry Advisor

FDA Streamlines Review Process for Premarket Tobacco Applications

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

How the FDA process is biased against new technology

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 ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

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 ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

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 ...
RAPS

Advanced manufacturing: Industry tells FDA process modeling is sufficient for batch uniformity

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 ...
Regulatory Affairs Professionals Society

FDA finalizes two guidances for industry on establishing bioequivalence

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 ...