Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program

In this report, we describe the collective experiences of industry participants in the MIDD Program to date, including all aspects of the process from meeting request submission to follow-up actions. The purpose is to provide future participants with information to optimize the value of the MIDD Program.PMID:38519861 | DOI:10.1002/cpt.3245

Source: Clinical Pharmacology and Therapeutics - March 23, 2024 Category: Drugs & Pharmacology Authors: Gerald R Galluppi Malidi Ahamadi Souvik Bhattacharya Nageshwar Budha Ferdous Gheyas Chi-Chung Li Yuan Chen Anne-Ga ëlle Dosne Niels Rode Kristensen Mindy Magee Mahesh N Samtani Vikram Sinha Kunal Taskar Vijay V Upreti Jianning Yang Jack Cook Source Type: research