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Torbeck RL, Schilling L, Khorasani H, Dover JS, Arndt KA, Saedi N

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1-4 Products approved via the 505(b)(2) regulatory pathway 6-9 : Contain full safety and effectiveness reports , based at least in part on the originator products data Allow for changes in product characteristics that may support operational efficiency , such as ready-to-use formulations or other differences in dosage form, strength, or route of administration As with all FDA-approved medicines, products approved under the 505(b)(2) pathway undergo rigorous evaluation to assess for efficacy, safety, and quality

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