Companies Submit Petition Requesting FDA Clarify Off-Label Rules

Seven of the world’s largest pharmaceutical and device companies are urging the FDA to spell out its policies for off-label use communications, citing a significant lack of clarity. Allergan, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer and Sanofi filed a joint citizen petition Tuesday, requesting comprehensive guidance on what sort of off-label communications the agency permits.
Drug Industry Daily