FDA-ISoP Public Workshop: Model Informed Drug Development (MIDD) for Oncology Products
Under the FDA Reauthorization Act of 2017, FDA agreed, in accordance with section I of the PDUFA VI Performance Goals, Ensuring the Effectiveness of the Human Drug Review, part J, Enhancing Regulatory Decision Tools to Support Drug Development and Review, to convene a series of workshops to identify best practices for model informed drug development (MIDD).
The FDA and the International Society of Pharmacometrics (IsoP) will jointly convene a workshop on model informed drug development for oncology products as part of this workshop series. You may choose to register for in-person attendance, or you may view remotely via the live Adobe Connect (audio/video) option. The Adobe Connect link will be emailed to those who select that option closer to the meeting date.
Date: February 1, 2018 from 8:00 a.m. to 5:20 p.m.
Location: FDA White Oak Campus/10903 New Hampshire Avenue/ Building 31, Room 1503 - Great Room B & C/ Silver Spring, MD 20993
Meeting Information: DRAFT Agenda - MIDD for Oncology Products Workshop