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.
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Guidance To Put More Combo Products Into Device Realm Due Out In Fall, FDA Commish Gottlieb Tells Congress
A combination products guidance “to move more products into the device realm” will be released either at the end of this summer or in early fall, US FDA Commissioner Scott Gottlieb told lawmakers at a hearing. He also explained how new 21st Century Cures authority to hire biomedical scientists with very specific expertise will help the agency.
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
FDA officials discuss difficulties dealing with complex combination products, the future of the agency's product centers, and promotion of industry collaboration at the Drug Information Association's annual meeting.