US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies US 505(b)(2) Regulatory Pathway and Strategies
from mediaserver.aaps.org
More from this publisher
13.07.2015
Views
505(b)(2) Risks• Imprecise development costs and timelines– ANDA‟s have few re-do‟s of BE– Recruitment of patients not naive– Uncertain dose (Phase 2)• Unknown competition– Other companies can target the same opportunity20
505(b)(2) Risks• Uncertain market acceptance– Formulary– Sales Force– Doctors– Patients21
- 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 and 8: 505(b)(2) NDAReference Listed Drug
- 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: Benefits of 505(b)(2)• Get out of
- Page 23 and 24: 505(b)(2) Risks• Like Generics (5
- Page 25: Thank You• Regulatory Sciences Co
<strong>505</strong>(b)(2) Risks• Imprecise development costs <strong>and</strong> timelines– ANDA‟s have few re-do‟s of BE– Recruitment of patients not naive– Uncertain dose (Phase 2)• Unknown competition– Other companies can target the same opportunity20
Change language