Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FD (Medical Devices)
Venue: Online Event
|Event Date/Time: Aug 28, 2012||End Date/Time: Aug 28, 2012|
Why Should You Attend:
The webinar is intended to provide participants with strategies for drafting targeted and effective Citizen Petitions and Suitability Petitions for submission to FDA. Recommendations for strengthening petitions and increasing the chances of ultimate success will also be provided.
Attendees will learn techniques for drafting and filing successful petitions. The presenter will share info on where to find relevant FDA regulations and guidance documents; the required parts of a petition; the scientific evidence and data needed to support a request; and how to file such a petition. The types of requests generally and examples of specific requests will be covered. The instructor will also provide a legal analysis of recent approval trends to help participants identify the types of issues and petitions that are finding success at FDA.
The session will also highlight amendments to the Federal Food, Drug, and Cosmetic Act in 2007 intended to curb branded drug manufacturers from abusing the petition process for the purpose of delaying generic approvals. Because of those changes, FDA is no longer allowed to delay the approval of a pending ANDA unless a delay is necessary to protect the public health.