Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Extension of Comment Period

Streszczenie

The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice of public meeting entitled "Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments" that appeared in the Federal Register of July 9, 2019. In the notice of public meeting, FDA requested comments on the use of complex adaptive and other novel investigation designs, data from foreign countries, real world evidence, and biomarkers and surrogate endpoints in animal drug development and regulatory decision making. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.