Category: Regulatory/FDA

Risk Communication Advisory Committee to Discuss Communicating Uncertainty, Multiple Risks

PhRMA, Industry Members Object to TV Ad Review Draft Guidance

FDA Looks to Consumers for Pre-approval Input

Common Marketing Violations Still Occurring, OPDP Says in 2012 Q1 Enforcement Webinar

Guest Column: Heavy Meddle by Peter Pitts

Proposed OTC Drug Distribution Would Expand Patient Access to Rx Drugs

PDUFA V Bills Moving Forward Without Specific Marketing Provisions

CHC and TAC Comments Object to “Dual Modality” Risk Communication in DTC TV Ads

FDA Draft Guidance on DTC TV Ads Raises Important Questions