2015 - FDA ? Alternative Strategies in Dealing with the Agency to Develop and Gain Approval of Drugs and Medical Devices

DESCRIPTION
Why you should attend
Executives (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:
Regulatory, Research & Development, Compliance, Quality Assurance, Medical Affairs, Clinical Affairs, Clinical Operations, Legal
Description of the topic
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. In this webinar, we will explore those mechanisms for both drug (and biologic) and device (incuding diagnotics) 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, we will review how to qualify for these programs, their benefits, and their burdens, all with aim of helping you, where possible, get your product to the market faster while still satisfying the legal requirements for approval.
Areas Covered In the Sem