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Home » Woodcock Says 505(b)(2) Filers Need Not Cite ‘Most Similar’ Listed Drug
Woodcock Says 505(b)(2) Filers Need Not Cite ‘Most Similar’ Listed Drug
September 30, 2013
Drugmakers filing 505(b)(2) applications are not required to reference the “most similar” listed drug as long as they can prove reliance on the chosen listed drug is scientifically justified, CDER Director Janet Woodcock says.