FDA Revises MAPP for Regulatory Project Management Site Tours
Posted 27 March 2012 | By
A newly-revised manual of policies and procedures (MAPP) document released by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research outlines the policies and procedures for selecting pharmaceutical companies for participation in FDA's Site Tours Program (STP) and how FDA oversees the program.
FDA uses the Site Tours Program to experience the drug development process from an industry perspective, share regulatory project management information and learn more about industry. The program has existed since 1999, and is overseen by CDER's Regulatory Project Management Coordinating Committee (RPMCC).
Companies interested in participating in the STP should keep an eye out for Federal Register postings inviting participation. The tours are FDA-funded, and priority consideration is given to companies that have not participated in the program in the prior three years.
FDA - 7500.2Rev1 (PDF - 59KB)Regulatory Project Management Site Tours and Regulatory Interactions Program (Issued 3/26/2012, Posted 3/26/2012)