CDER Pilot Program Offers Potential New Pathway For Approval Of Novel Pharmaceutical Excipients

After decades without an approval pathway for excipients, FDA pilot program paves the way for innovation.

A path forward
a new road for excipient approval • Source: Alamy

With its launch of a pilot program for the review of novel excipients, the US Food and Drug Administration is generating excitement over what could become a more workable approval pathway than the drug application process.

Despite the industrywide benefits of novel excipients, it is rare for applicants to complicate their submissions and risk approval delays...

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