Drugs

Comments on IND Communications with FDA

The Alliance for Regenerative Medicine says CBER was under-represented in an independent third-party review assessment of FDA-sponsor communication practices during the IND stage of new drug/biologic development. The group says that “in light of the resource constraints and staggering number of active INDs with CBER,” FDA should devote a follow-up report to CBER practices. It also suggests a review be conducted assessing FDA and sponsor interactions before IND submission.

In its comment, Pharmaceutical Research and Manufacturers of America (PhRMA) says it would like to work collaboratively with FDA to “examine issues related to meeting management and develop best practices that can enable improvements to provide enhanced engagement and predictability for sponsors while alleviating the increased burden on the agency and ensuring a sustainable workload. PhRMA believes that efficient FDA engagement with sponsors is essential to bringing important new medicines to patients in a timely manner…. PhRMA looks forward to working with FDA to identify best practices for FDA-sponsor interactions during the IND phase to optimize the efficiency of the IND process.”

Bayer says that communication during the IND phase is critical, as is the assessment that identifies opportunities to enhance the communications. The company lists several suggestions to improve IND communications.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome