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.
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Additions could help streamline generic development, Center for Drug Evaluation and Research Director Patrizia Cavazzoni says.
The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.
Proposal could yield a bounty of new options for innovative drug delivery systems.