Creative Strategies in Dealing with FDA
$159.00 — $179.00
In tackling the challenge of developing a drug or device product for FDA approval, a common assumption is that the effort will take years and cost the budget of a small city. And, then, when you file at FDA, you worry that you will have to wait forever for a decision. While there is some truth in that hyperbole, the reality is that there are a number of programs available at FDA that are designed to speed the development and approval process. This webinar will explore those mechanisms for both drug (and biologic) and device (including diagnostics) products.
Ranging from the new “breakthrough drug” provisions of the 2012 Food & Drug Administration Safety and Innovation Act (FDASIA) to the protocol assistance requirements of the 1983 Orphan Drug Act to the Special 510(k) process, this presentation will review how to qualify for these programs, their benefits, and burdens, all with aim of helping you, where possible, get your product to the market faster while still satisfying the legal requirements for approval.
Join this webinar to explore in detail the benefits of programs, the eligibility criteria for programs, how the various programs compare, and also explore strategies in deciding which to use when multiple options may be available.
Who should attend:
Executives (including VPs, Directors, Managers) and other professionals involved in developing and executing the strategies to secure approval/clearance of FDA-regulated drugs, biologics, and medical devices and diagnostics. In particular, professionals from these functional arenas
- Executive Management –the C-Suite
- Quality Assurance
- Regulatory Affairs
- Medical Affairs
- Research & Development
- Clinical Operation
- Clinical Affairs
- All personnel who want to learn how to interact with FDA