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.
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The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.
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 US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.