FDA Suggests Use of Biomarker Qualification Program as Possible Model for Approving Novel Excipients
This article was originally published in The Gold Sheet
Executive Summary
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.
You may also be interested in...
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.
US FDA Mulls Pilot To Examine Separate Review Pathway For Novel Excipients
Proposal could yield a bounty of new options for innovative drug delivery systems.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”