On Tuesday, November 8, 2022, as part of the GRx+Biosims conference being held by the Association for Accessible Medicines, Marty Shimer will be participating on a panel in the Science and Regulatory Learning Track on pH Adjusters and Q1/Q2 Assessments. This session will explore FDA’s plans for pH adjusters and Q1/Q2 assessments and provide industry perspectives on how differences to pH adjusters through a waiver under 21 CFR 314.99(b) demonstrating how they could help improve the efficiency of generic drug development and expand access to safe and effective generic medicines. Marty is one of five speakers on this panel and will be joined by three panelists from the FDA Office of Generic Drugs, which is moderated by Molly Ventrelli. We hope to see you there!
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