Category: Regulatory/FDA

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

Medicare Doctor Payment Fix Legislation Is Best Vehicle for Sunshine Act Amendments

OPDP Enforcement Letters Target Common Issues in Last Half of 2013

Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Coalition Seeks Input on FDA Online Promotion Guidance

CMS: Textbooks and Reprints Do Not Fall Under Sunshine Act Statutory Exclusion

CHC Briefing to Provide Medical Marketers With Preview of How Washington Will Affect Their 2014

Dale Cooke: New Product Name Placement Draft Guidance Rights Wrongs from 2012 Update