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PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications. Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed,...more

Five Lessons From OPDP's First Enforcement of 2015: (Lack of) Precision Carries the Day

The first Untitled Letter of 2015 from the Office of Prescription Drug Promotion (OPDP) provides valuable lessons on drug promotion. OPDP issued its first Untitled Letter of 2015, after a 2014 relatively light on...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

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