This activity was originally recorded on Tuesday, July 12, 2022. The activity EXPIRED on July 12, 2023, and is no longer available for CME credit, but the recording is still available for viewing.
About the Webinar
Use of cellular therapies in medicine is evolving at a rapid pace. Organizations such as the FSMB and the FDA have attempted to provide clear guidance to the medical and regulatory communities as a way to caution physicians about the use of stem cell therapies and other biologics, and to ensure their actions are compliant with both state and federal law. During this webinar, FDA staff will provide an introduction to stem cells and cellular therapies ("stem cells 101") and the FDA rules and regulations governing their use. The speakers will specifically highlight various types of cellular therapies and other purported regenerative medicine products currently regulated by the FDA and walk through portions of FDA's guidance that provides the agency's current thinking on these products.
About the Speakers
Rachael Anatol, PhD, is Deputy Director of the Office of Tissues and Advanced Therapies (OTAT); Center for Biologics Evaluation and Research (CBER); US Food and Drug Administration (FDA). Prior to this role, for 8 years Dr. Anatol served as an Associate Director of Policy in OTAT (formerly the Office of Cellular, Tissue, and Gene Therapies). Dr. Anatol received her Ph.D. in molecular and cell biology from the University of Maryland, College Park and completed her post-doctoral training at NIH’s National Heart, Lung, and Blood Institute.
Melissa Mendoza, JD, is the Acting Director of the Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). OCBQ is responsible for ensuring the quality of products regulated by CBER over their entire lifecycle, from pre-market review and inspection to post-market review, surveillance, inspection, outreach, and compliance. Before joining CBER, Melissa served as Associate Chief Counsel for Enforcement in FDA's Office of the Chief Counsel.
About the Moderator
Humayun “Hank” Chaudhry, DO, MACP, is the President and Chief Executive Officer of the FSMB. From 2016 to 2018 Dr. Chaudhry also served as Chair of the International Association of Medical Regulatory Authorities (IAMRA), which represents 116 members in 48 nations. Dr. Chaudhry is a graduate of New York University, the New York Institute of Technology (NYIT) College of Osteopathic Medicine and Harvard University’s School of Public Health. He completed an internship at St. Barnabas Hospital in New York, followed by an ACGME-accredited residency in Internal Medicine at Winthrop-University Hospital, New York, where he spent an additional year as Chief Medical Resident.Dr. Chaudhry spent 14 years with the United States Air Force Reserve, rising to the rank of Major and serving as a Flight Surgeon. He spent two years as Health Commissioner for Suffolk County, New York, overseeing 1,300 employees and a budget of $400 million. He is co-author of “Fundamentals of Clinical Medicine,” 4th edition and “Medical Licensing and Discipline in America,” and in 2016, Dr. Chaudhry was recognized by Modern Healthcare magazine as one of the 50 Most Influential Physician Executives and Leaders in America
Target Audience
This activity was designed specifically for physician and public members, as well as leadership staff of the state medical and osteopathic licensing boards, and others within the medical regulatory community.
Learning Objectives
Upon completion of this educational activity, participants should be able to:
- Possess a working knowledge of the use of human cells, tissues and cellular and tissue-based products in medicine.
- Describe the FDA rules and regulations governing the use of current stem cell therapies.
- Discuss the role state medical boards play in educating both physicians and the public of applicable federal and state regulations.
- Describe the process for reporting adverse actions related to stem cell interventions.
Accreditation Statement
The Federation of State Medical Boards is accredited by the
Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.Credit Designation Statements
The Federation of State Medical Boards designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The Federation of State Medical Boards certifies that non-physicians will receive an attendance certificate stating they participated in the activity that was designated for 1.0 AMA PRA Category 1 Credit™.
Disclosure Declaration
As an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Federation of State Medical Boards (FSMB) requires that the content of CME activities and related materials provide balance, independence, objectivity, and scientific rigor. All faculty, planners, and others in a position to control continuing medical education content participating in an accredited continuing education activity are required to disclose all financial relationships with ineligible companies. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Faculty (authors, presenters, speakers) are encouraged to provide a balanced view of therapeutic options by utilizing either generic names or other options available when utilizing trade names to ensure impartiality.
All faculty members are asked to disclose all financial relationships they have had in the past 24 months with ineligible companies regardless of the potential relevance of each relationship to the education and of the amount. The FSMB has implemented a mechanism to identify and resolve all conflicts of interest prior to the activity. The intent of this policy is to identify potential conflicts of interest so participants can form their own judgments with full disclosure of the facts. Participants will be asked to evaluate whether the speaker’s outside interests reflect a possible bias in the planning or presentation of the activity. The following indicates the disclosure declaration information and the nature of those commercial relationships.
The speakers, course director, and planners at the Federation of State Medical Boards, have nothing to disclose.
System Requirements
In order to view this presentation, your computer must have audio capabilities (working speakers or headphones) and must have an internet browser capable of playing an HTML5 video.
Instructions for Participants and Obtaining CME Credit
There is no fee for this activity. To receive credit and receive their certificates, participants must view this CME activity in its entirety and complete the evaluation. The estimated time for completion of this activity is 1 hour.