GMP Requirement Guidance For Combination Products Satisfies Industry
The guidance clarifies what constitutes a convenience kit, whether sponsors must submit GMP information in marketing applications and the applicability of combination product regulations to cross-labeled combination products.
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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help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.
The document provides real-world tips demonstrating how the agency expects manufacturers to apply GMP rules to combination products. It's linked to a 2013 rule on the subject.