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Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement

 
• By Joanne S. Eglovitch

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.

collage assortment of pills and capsules of colours
FDA's Proposed Program For Novel Excipients Supported By Industry • Source: Shutterstock

Pharmaceutical manufacturers and excipient suppliers lent their support to the US Food and Drug Administration’s proposal to establish a new program for novel excipients but urged the agency to refine its proposal first. They called for clarification on what is meant by a novel excipient and expansion of the program to other types of excipients such as those used in food.

Most if not all 26 comments on the FDA’s plan to establish a program for novel excipients

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