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

13.07.2015 • Views

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

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

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Industry ExamplesHighlighting the Benefits of utilizing the<strong>505</strong>(b)(2) <strong>Regulatory</strong> <strong>Pathway</strong>9

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Industry ExamplesHighlighting the Benefits of utilizing the<strong>505</strong>(b)(2) <strong>Regulatory</strong> <strong>Pathway</strong>9

Page 1 and 2: US 505(b)(2) RegulatoryPathway and
Page 3 and 4: Differentiated Products Now Essenti
Page 5 and 6: 505(b)(2) RegulationPotential 505(b
Page 7: 505(b)(2) NDAReference Listed Drug
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