FDA’s New ANDA Pilot: A Win for U.S. Manufacturing
FDA’s ANDA Prioritization Pilot: What It Means for U.S. Generics and CDMOs
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Pharma Tariffs Push for U.S. Production
What the New Pharma Tariff Means for CDMOs and Sterile Injectables The U.S. just announced a propose...
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American Injectables Earns FDA Approval
BROOKSVILLE, FL (January 9, 2025) — American Injectables, a contract development and manufacturing o...
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Developing a Regulatory Strategy: Key Studies in the Formulation Stage
The FDA approval process is time-intensive and difficult for good reason. If you emerge on the other...
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