Editors' ChoiceU.S. Food and Drug Administration

Understanding the Regulatory Pathway One Video at a Time

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Science Translational Medicine  03 Aug 2011:
Vol. 3, Issue 94, pp. 94ec124
DOI: 10.1126/scitranslmed.3002989

For scientists who have spent much of their time in classrooms and lecture halls, it is second nature to learn by instruction, and Web-based seminars (webinars) or online video tutorials delivered via broadband connections have facilitated learning at home or at the office desk. With the current advances in regenerative medicine, many investigators will for the first time be approaching the U.S. Food and Drug Administration (FDA) with the desire to evaluate their innovative products in clinical trials. Here, we describe new resources to facilitate the path from bench to bedside for translational academic scientists and companies.

Indeed, the FDA provides a variety of resources through www.fda.gov to assist investigators as they navigate the FDA submission process. However, even with these resources, the regulatory process can be challenging, especially for complex products. Regenerative medicine products often consist of a biologic, such as cells, and a device, such as a scaffold made of a synthetic polymer, that may serve as a delivery substrate. For such intricate and resource-intensive products, a detailed understanding of the regulatory process is pivotal to ensure that the transition from discovery to clinical trials is as uneventful as possible. Guidance documents issued by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) provide scientific and regulatory information. However, regenerative medicine scientists can also benefit from a more tutorial approach.

Sensitive to this need, CDRH and CBER’s Office of Cellular, Tissue and Gene Therapies (OCTGT) has developed online video tutorials given by FDA staff who are knowledgeable about regenerative medicine and regulatory science. These tutorials, CDRH Learn and OCTGT Learn, are designed to reach a broad audience in a personalized manner, covering regulatory topics that range from premarket to postmarket aspects of product development under the auspices of these two centers.

CDRH Learn presents online video tutorials in English, Spanish, or Chinese and includes topics such as “Overview of Regulatory Requirements: Medical Devices” and “Investigational Device Exemption Process—IDE.” An IDE is a required regulatory submission needed to obtain FDA permission to initiate a clinical trial for a medical device.

The OCTGT Learn online video tutorials cover diverse products regulated by OCTGT, including cell and gene therapies and tissue-engineered products. This series focuses on product development to enable initiation of early-phase clinical trials. Topics range from “IND [Investigational New Drug] Basics in OCTGT” to “Preclinical Considerations for Products Regulated in OCTGT.” An IND is a required regulatory submission needed to obtain FDA permission in order to initiate a clinical trial for an investigational pharmaceutical agent. Also offered is a tutorial entitled “Sponsor Meetings with OCTGT,” which provides a step-by-step explanation of various procedures for meeting with this CBER office. This particular tutorial is especially helpful to investigators who are approaching CBER/OCTGT for the first time, because it covers the types of meetings offered, instructions on how to request a meeting, information on what to submit to OCTGT before a meeting, and the type of response investigators can expect from OCTGT during the meeting.

This unique online source of comprehensive interactive instruction guides researchers through the regulatory process to encourage the development of promising regenerative medicine therapies.

FDA. Device Advice: Comprehensive Regulatory Assistance.

FDA. Guidance, Compliance & Regulatory Information (Biologics).

FDA. CDRH Learn. [video tutorial] 12 October 2010.

FDA. OCTGT Learn. [video tutorial] 28 January 2011.

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