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Our feature article this month is a review of the FDA’s recent guidance on OFF-LABEL communications. We also begin a two-part series on STATE and LOCAL activities to regulate the pharmaceutical industry starting with a look at PRICING TRANSPARENCY initiatives. Commercial interactions with PATIENTS and PATIENT ADVOCACY groups is next followed by the latest developments with Ohio’sDRUG SAMPLE VERIFICATION rules. We round out the month with the latest on ENFORCEMENT and WHISTLEBLOWERS.
The Never-Ending Saga of Off-label Promotion
Jenny McVey, Associate Director, FRA Life Sciences
Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
The Expanding Frontier – Commercial Interactions with Patients and Patient Organizations
David Davidovic, Founder, pathForward; former Global VP, Commercial Services, Genentech and Roche
UPDATE: Round 2 with Ohio’s Drug Sample Verification Requirements
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC, Bryan Andrews, Director of Sales Operations, MedPro Systems LLC
Getting Serious About Fraud – The DOJ Charges 412
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Will Your Whistle Be Heard at Home?
Sally Foroughi, Staff Writer, Life Science Compliance Update