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

 
• By Joanne S. Eglovitch

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.

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...

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