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
Decision to Pursue the 505(b)(2) Regulatory PathwayConsiderations:• Willingness to take educated risks• In-house Expertise• Company Culture• Historical Precedence24
Thank You• Regulatory Sciences Co-Moderators– Michael Bornstein, PhD– Annette Bak, PhD, MBA• Rajneesh Taneja, PhD, RPh
- 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 and 20: Benefits of 505(b)(2)• Get out of
- Page 21 and 22: 505(b)(2) Risks• Uncertain market
- Page 23: 505(b)(2) Risks• Like Generics (5
Decision to Pursue the <strong>505</strong>(b)(2) <strong>Regulatory</strong> <strong>Pathway</strong>Considerations:• Willingness to take educated risks• In-house Expertise• Company Culture• Historical Precedence24
Change language