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 ...

Washington State University fired up the grill for “CRISPR sausages” made with pork from gene-edited pigs. WSU is the first university to make meat from gene-edited livestock available for human ...

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed ...

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 ...

Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to ResearchAndMarkets.com's offering. This FDA Process Validation Training ...

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...

Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...

Many physicians are unfamiliar with how the Food and Drug Administration’s (FDA) regulates new drugs and medical devices, and they may be under the impression that the data supporting these approvals ...