Combo Product Appeals Low In Number, But Lengthy In Decision Time
US FDA needs to establish timelines for decisions on appeals of requests for designations of combination products, industry expert says; FDA contends that decisions on appeals carry significant implications, and require thorough reviews.
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No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.
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help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.
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