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Novel Excipient Review Pilot Program Overview and Q&A

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Overview of the Novel Excipient Review Pilot Program followed by Q&A.

The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. This Pilot Program will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients. (Source)

Audience

Roles
> Research & Development
> Quality
> Regulatory
> Formulations

Industry Segments
> Pharmaceutical - Originator Drugs
> Biologics - Biotech Drugs (Originators)
> Medical Device / Combination Products
> Consumer Goods (Medical Products)

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