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Session 6: Navigating Pre-Approval Communications: Developing Compliant Strategies Across the Product Lifecycle
Session Chair(s)
Mary Johnson, PhD, RAC
Consultant, StratPhD LLC, United States
Discuss strategies and practical review considerations for disease awareness and pre-approval communications, including products with existing indications and rare diseases. Explore pre-approval information exchange (PIE), approaches to reviewing materials, and the needs, questions, and considerations that shape the review process.
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