Recent developments regarding a Novel Excipient Qualification process

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) and the International Pharmaceutical Excipients Council of the Americas (IPEC- Americas) are working toward accelerating excipient innovation and ways to bring forth novel excipients with enhanced functionality that improve drug delivery and manufacturability (e.g., continuous manufacture) and that focus more on the needs of special populations (e.g., pediatrics). This collaboration led to a Critical Path Initiative Meeting (CPIM) with the FDA on March 10 to discuss developing an independent Novel Excipient Qualification process that encourages the development of innovative novel excipients and their use.

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