U.S. Food and Drug Administration accepts Soluplus® branded excipient in its program to evaluate safety and acceptability of excipients for use in clinical trials, independent from a specific New Drug Application.
Excipients (inactive ingredients) such as the Soluplus® branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
Pharma Solutions announces today that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of New Drugs, has accepted their excipient, Soluplus®, into the FDA’s Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME). The program
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