US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies US 505(b)(2) Regulatory Pathway and Strategies
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13.07.2015
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Approved Product LabelingDrug SubstanceIndicationSafetyClinicalPharmacologyDDIPharmacokineticsReproductive8
Industry ExamplesHighlighting the Benefits of utilizing the505(b)(2) Regulatory Pathway9
- 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
Industry ExamplesHighlighting the Benefits of utilizing the<strong>505</strong>(b)(2) <strong>Regulatory</strong> <strong>Pathway</strong>9
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