The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.
On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot ...
Vietnam Investment Review on MSN
FDA establishes first MSC quality control protocol
TIANJIN, China, Jan. 26, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) ...
In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control ...
GlobalData on MSN
Why pharma manufacturers are still investing in Europe
Despite being saddled with tariffs and lagging behind China and the US, European sites offer biopharma suppliers a chance to ...
FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S.
US FDA launches PreCheck pilot programme to strengthen domestic pharmaceutical manufacturing: Silver Spring, Maryland Tuesday, February 3, 2026, 14:00 Hrs [IST] The US Food and Dr ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
Discusses Integrated Prefillable Syringe Systems to Streamline Drug Development and Reduce Complexity February ...
M4Q (R2) is a globally harmonized framework for structuring quality information in medicinal product registration ...
EXPANSION ADDS STATE-OF-THE-ART UPSTREAM AND DOWNSTREAM GMP PROCESSING CAPABILITIES TO MEET THE GROWING DEMAND FOR 2,000 ...
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