Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA 2012 is a webinar that covers topics such as:
- 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
Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA 2012 brings together:
- 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
