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Caption: A Primer On The 505 b 2 Pathway For Combination DrugDevice Products

Subject: Most combination products in the U.S. are reviewed primarily by FDA rsquo;s Center for Drug Evaluation and Research CDER . Of these, many approvals occur via the ldquo;abbreviated rdquo; 505 b 2 regulatory pathway. So, what is the 505 b 2 pathway, and how can it save you time and money?

Keys: meddeviceonline, combination, products, pathway, primer, device, 505b2, drug, 0001, com, doc, the, for

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