Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement
The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.
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FDA Suggests Use of Biomarker Qualification Program as Possible Model for Approving Novel Excipients
To encourage the development of novel excipients, FDA has suggested retooling its existing Biomarker Qualification Program from new drugs to new excipients. Instead of using this model solely to qualify the safety of new drugs, it also can be used to assess the safety of new excipients.
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.