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 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 ...
Forbes contributors publish independent expert analyses and insights. Tor Constantino is an ex-reporter, turned AI consultant & tech writer. In a landmark for U.S. public health digital transformation ...
The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal ...
Vietnam Investment Review on MSN
C Ray Therapeutics receives FDA acceptance for copper 64 file
CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been ...
IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 Million People Living with Osteoarthritis Our concurrent request for RMAT ...
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