Media

2026

Beyond the Data - FDA's White Paper on Digitally Derived Measures

This LinkedIn Live explored FDA's cross-center white paper on digitally derived measures in clinical investigations, focusing on what makes a digital measure fit for its intended purpose and the practical questions to address before a protocol locks.

Host:
Chad Patel
Denise Sanchez

FDA Revised Draft Guidance - Substantial Evidence (June 2026)

This briefing explored FDA's June 2026 revised draft guidance on substantial evidence, focusing on how FDA is framing the standard, why trial execution can affect evidentiary strength, and where real-world evidence fits.

Host:
Denise Sanchez

Beyond the Update - FDA's Revised Payor Communications Draft Guidance

This LinkedIn Live explored FDA’s revised draft guidance on manufacturer communications with payors, focusing on what has changed and what it means in practice for Regulatory, HEOR, and Market Access teams.

Host:
Chad Patel
Denise Sanchez

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