Pfenex Announces FDA Requests Additional Comparative Use Human Factors Data in Experienced Users in Order to Complete PF708 Therapeutic Equivalence Determination
April 14, 2020 at 05:19 pm
Pfenex Inc. announced that the U.S. Food and Drug Administration (FDA), informed Alvogen Malta Operations Ltd., the Company’s commercialization partner for PF708, via a General Advice letter that additional comparative use human factors (CUHF) data, specifically from Forteo® (teriparatide injection) experienced users, would be required before PF708 Therapeutic Equivalence (TE) could be determined.