Clinical Supply Regulatory Articles
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The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials
5/12/2025
Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.
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Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations
6/2/2025
The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).
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Have We Got Novel Drug Production And Compliance Timelines All Wrong?
6/13/2024
Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.
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7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies
7/3/2025
The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.