Common Combo Product Designation Mistakes To Be Outlined In Upcoming Guidance
US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.
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OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.
Commissioner Gottlieb says upcoming guidance could help nudge products into preferred device realm if they are on cusp between drug or device jurisdictional designation.
Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.