Category: Regulatory/FDA

Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

OPDP Issues First Untitled Letter for Branded Facebook Page

Cuts in Speaker Payments Should Be Placed in Proper Context

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses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