FDA Updates the Office of Prescription Drug Promotion Core Launch Review Process
Today, the Food and Drug Administration is announcing updates to the Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion (OPDP) Core Launch Review process and has published new frequently asked questions to assist firms in understanding these updates.
Over the past several years, OPDP has evaluated trends in core launch material submissions (e.g., sales and visual aids, patient brochures, professional journal and magazine ads) from sponsors requesting advisory comments on promotional materials, in addition to reviewing internal OPDP business processes. To provide timely feedback to firms, ensure submissions are complete and reviewable, and maximize use of OPDP’s resources, OPDP is updating the core launch review process. OPDP has added a 5-business day core launch screening period to the launch review process and has provided additional clarification on OPDP’s definition of core launch.
On November 20, 2020, OPDP is hosting a webinar to provide an overview of the upcoming changes to the OPDP Core Launch Review process. The webinar will provide information to:
• Identify promotional materials that qualify for Core Launch Review within the OPDP Advisory Process
• Understand the changes to the Core Launch Review process and incorporate those changes into existing promotional material development strategies
• Utilize the various resources provided by OPDP to support the Core Launch Review process
For more information on the webinar and to register, please visit the FDA News & Events webpage.
|
