FDA Suggests Use of Biomarker Qualification Program as Possible Model for Approving Novel Excipients

To promote the development of novel excipients, FDA has suggested building upon the agency’s existing Biomarker Qualification Program (BQP) but to apply this model to new excipients.

FDA officials said that the program was established to promote the development of new drugs but could be retooled for novel excipient development as well.