This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.
This webinar will provide an essential review of the key do's and don’ts for a 505(b)(2) application. Specifically the presentation will provide the information for companies to choose appropriate 505(b)(2) candidates, and to successfully advance them through development.
Why Should You Attend:
Despite its significant advantages, the 505(b)(2) pathway presents unique scientific, regulatory and legal challenges. Accordingly, knowledge of this regulatory pathway is important for all firms with an interest in utilizing the 505(b)(2) pathway as a means of building their drug portfolios, and also to better understand their competitors who are utilizing this pathway.This webinar will provide an essential review of the key do's and don’ts for a 505(b)(2) application. Specifically the presentation will provide the information for companies to choose appropriate 505(b)(2) candidates, and to successfully advance them through development.
Areas Covered in the Webinar:
- History of the 505(b)(2) NDA
- Strategic considerations for 505(b)(2) projects and common mistakes
- Examples of 505(b)(2) candidate projects
- Intellectual property issues and non- patent exclusivity
- Key development steps for 505(b)(2) candidates
- 505(b)(2) benefits and risks
- Trends in FDA review of 505(b)(2) applications; key regulatory issues
- Examples of successes and failures for 505(b)(2) projects
Who Will Benefit:
This webinar will provide valuable information to professionals in:- R&D
- Regulatory Affairs
- Clinical Research
- Business Development and Product Portfolio
- Marketing
- Project Management
- Intellectual Property
Course Provider
Thomas Reilly,
