
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
Read MorePharma Tariffs Push for U.S. Production
What the New Pharma Tariff Means for CDMOs and Sterile Injectables The U.S. just announced a propose...
Read More
1 Min. Read
American Injectables Earns FDA Approval
BROOKSVILLE, FL (January 9, 2025) — American Injectables, a contract development and manufacturing o...
Read More
1 Min. Read
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...
Read More
3 Min. Read