Whether product will require a cder or cber review, Other Subject

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Whether product will require a cder or cber review

Problem: A U.S. Manufacturer has created a Drug/Biologic combination product formulation. In developing the regulatory strategy for this product's appropriate approval what would be the process to evaluate whether this product will require a CDER or CBER review?

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Other Subject: Whether product will require a cder or cber review

Reference No:- TGS03307038

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Other Subject: Whether product will require a cder or cber review

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