Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA 2012

Topics

• The requirements for preparing and submitting petitions to FDA
• FDA`s regulation of Citizen Petitions and Suitability Petitions
• 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 types of submitted petitions and requests that have been successful
• A company`s options when FDA denies a filed petition
• The type of changes that can be requested with a Suitability Petition for a proposed generic drug product

Who should Attend

• Managers, Consultants, Scientists, Research Analysts, State Policy Officials
• 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
• Investment Analysts, Venture Capitalists, Financial analysts, investors watching the pharmaceutical, life sciences and biotech industries