Pharma Blog Watch

CMC Pilot Program (On Pharma)
In her blog, Agnes Shanley discusses a talk about drug development given by Moheb Nasr, the FDA's director of the Office of New Drug Chemistry, at the International Society for Pharmaceutical Engineering meeting last week. Specifically, he spoke about the FDA's Quality Assessment, Manufacturing and Control (CMC) Pilot Program, "which allows applicants to propose a regulatory strategy specific to a product and/or process."

He explained that "pharma companies must shift from the old mantra of 'how can I put as little information as possible into this application,' to 'how can I facilitate a review based on good science'," she writes. "Some companies may not 'get it,' but an increasing number are taking FDA up on its offer for more dialogue: 12 applications were submitted to the CMC Pilot Program, of which 11 applications were accepted — 2 have been approved, 3 are under review and another 6 remain to be formally submitted."