PDUFA First: Fees To Support US FDA Device Center Staff
To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.
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User-Fee Facts: 10 Key Medtech Details From US FDA Agreements
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.
US FDA: No Timeframe On Combo Products Council Response To Industry Feedback
Industry stakeholders are still confused about the scope of the recently formed Combination Products Policy Council. In the meantime, the council says it doesn't have a specific timeframe by which it will address the issues industry has identified as priority topics.
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.