US 505(b)(2) Regulatory Pathway and Strategies

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Defining the 505(b)(2) ApplicationA 505(b)(2) application is one for which one or more of the investigationsrelied upon by the applicant for approval "were not conducted by or forthe applicant and for which the applicant has not obtained a right ofreference or use from the person by or for whom the investigationswere conducted" (21 U.S.C. 355(b)(2)).
505(b)(2) NDAReference Listed Drug (RLD)• A drug product that has been previouslyapproved by the FDA• Listed in the Orange Book• Approval documents contain some of theinformation needed for your 505(b)(2)7
Page 1 and 2: US 505(b)(2) RegulatoryPathway and
Page 3 and 4: Differentiated Products Now Essenti
Page 5: 505(b)(2) RegulationPotential 505(b
Page 9 and 10: Industry ExamplesHighlighting the B
Page 11 and 12: Corporate StrategyMr. Sims: Actuall
Page 13 and 14: Case Study: Ulesfia TM - Excipient
Page 15 and 16: Pro-Drugs• Fundamental:- Where do
Page 17 and 18: Valacyclovir Regulatory Path• 505
Page 19 and 20: Benefits of 505(b)(2)• Get out of
Page 21 and 22: 505(b)(2) Risks• Uncertain market
Page 23 and 24: 505(b)(2) Risks• Like Generics (5
Page 25: Thank You• Regulatory Sciences Co

US 505(b)(2) Regulatory Pathway and Strategies

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