Events
Duane Morris Special Counsel Michael Swit to Examine "FDA–Alternative Strategies in Dealing with the Agency to Develop and Gain Approval of Drugs and Medical Devices"
February 21, 2013 | Webinar
Duane Morris special counsel Michael Swit will discuss "FDA–Alternative Strategies in Dealing with the Agency to Develop and Gain Approval of Drugs and Medical Devices" in a live webinar on Thursday, February 21, 2013.
In tackling the challenge of developing a drug or device product for Food and Drug Administration (FDA) approval, a common assumption is that the effort will take years and cost the budget of a small city. Once you file with the 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 explores those mechanisms for both drug (and biologic) and device (including diagnostics) products.
Ranging from the new "breakthrough drug" provisions of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to the protocol assistance requirements of the 1983 Orphan Drug Act to the Special 510(k) process, Mr. Swit will review how to qualify for these programs, as well as their benefits and their burdens, all with aim of helping attendees get products to the market faster while still satisfying the legal requirements for approval.
For more information, or to register, please visit the Compliance2go website.
