Gerald R Galluppi, Malidi Ahamadi, Souvik Bhattacharya, Nageshwar Budha, Ferdous Gheyas, Chi-Chung Li, Yuan Chen, Anne-Gaëlle Dosne, Niels Rode Kristensen, Mindy Magee, Mahesh N Samtani, Vikram Sinha, Kunal Taskar, Vijay V Upreti, Jianning Yang, Jack Cook
A recent industry perspective published in this journal describes the benefits received by drug companies from participation in the MIDD Pilot Program. Along with the primary objectives of supporting good decision-making in drug development, there were substantial savings in time and development costs. Furthermore, many sponsors reported qualitative benefits such as new learnings and clarity on MIDD strategies and methodology that could be applied to other development programs. Based on the success of the Pilot Program, the FDA recently announced the continuation of the MIDD Paired Meeting Program as part of the Prescription Drug User Fee Act (PDUFA VII)...
March 22, 2024: Clinical Pharmacology and Therapeutics