1. Medtech Insight

Companies Want New US FDA Council To Help Resolve Inter-Agency Combo Product Disputes

A range of topics were raised in feedback provided by industry groups to FDA about what the priorities should be for the agency's new Combination Products Policy Council, but addressing inter-center disagreements was a repeat concern. Also raised: misaligned communication policies; pediatric combo-product reviews; and implementation of the 21st Century Cures Act.

Manufacturers want a new US FDA Combination Products Policy Council to help establish a better approach to resolving inter-agency disagreements that arise during combo-product reviews, according to feedback garnered by the agency.

Review of combination products has been a complicated headache for FDA as well as manufacturers resulting in a range of internal reforms advanced by the agency

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