In the News: September 2021 Regulatory and Development Updates
Camargo
OCTOBER 14, 2021
The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.
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