Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA

This 90-minute webinar will recommend strategies for filing successful Citizen Petitions and Suitability Petitions with the U.S. Food and Drug Administration. You will learn techniques for drafting and filing successful petitions including the required elements of such petitions and the types of substantiation needed to support them.

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.

Areas Covered in the Seminar:

• FDA's regulation of Citizen Petitions and Suitability Petitions.
• The requirements for preparing and submitting petitions to FDA.
• The types of submitted petitions and requests that have been successful.
• FDA's June 2011 Guidance Document describing its standard for determining whether a petition raises an issue requiring the delay of a pending application to protect the public health.
• The type of changes that can be requested with a Suitability Petition for a proposed generic drug product.
• A company's options when FDA denies a filed petition.

Who Will Benefit:

• In-House Counsel, General Counsel, Asst. General Counsel, members of a company's Regulatory Affairs and Legal departments; and members of the branded pharmaceutical and generic drug industries generally.
• Managers, Consultants, Scientists, Research Analysts, State Policy Officials
• Investment Analysts, Venture Capitalists, Financial analysts, investors watching the pharmaceutical, life sciences and biotech industries