OPDP Core Launch Review Process Updated

The CDER Office of Prescription Drug Promotion (OPDP) has updated its core launch review process as explained in new frequently asked questions. OPDP says it has been evaluating trends in core launch material submissions such as sales and visual aids, patient brochures, and professional journal and magazine ads from sponsors seeking advisory comments on promotional materials.

The office has added a five business day core launch screening period and has provided additional clarification on its definition of core launch.

An 11/20 Webinar will give an overview of the upcoming changes to the core launch review process and will provide information to (1) identify promotional materials that qualify for core launch review within the OPDP advisory process; (2) understand the changes to the core launch review process and incorporate those changes into existing promotional material development strategies, and (3) use the resources provided by OPDP to support the core launch review process.