Combo Product Safety: US FDA Rule On Postmarket Reporting Nears Finalization
Industry is eagerly awaiting guidance on combination products, and after seven years the postmarketing reg may be at top of the agency’s queue.
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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help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.
US FDA’s final rule includes several clarifications about its scope and definitions, and includes some additional reporting requirements.
Final reg includes several clarifications about its scope and definitions, and also includes some additional reporting requirements.