Code of Federal Regulations for Research Use Only Products, FDA Guidance Documents, Labeling Requirements and GMPs

1. Overview
Research Use Only Products – the Dos and Don’ts
Date: Thursday, November 10th
, 2016, Time: 01:00 PM ET | 10:00 AM PT
Duration : 90 Minutes
Speaker: Harold Thibodeaux
For the past 30 plus years, the label “For Research Use Only” has been confusing to
many medical and research professionals as well as marketing and sales personnel.
Additionally, these products remain unregulated without Food and Drug Administration
(FDA) oversight. As the industry transitions into the age of molecular diagnostics to
remain innovative with the pharmaceutical industry efforts to develop medical products
for unmet medical needs, FDA regulatory oversight is need more than ever.
Although these products remain an important commercial class, a regulatory framework
to regulate their development, manufacture and distribution for the appropriate laboratory
intended use.
The topics for discussion in this webinar will be summarized to provide lists of dos and
don’ts for marketing, sales personnel, manufacturers and research professionals to
achieve their goals, remain compliant and to develop products that will be safe and
effective for use in patients. An appropriate regulatory framework will promote innovation
for those unmet medical needs instead of being an obstacle to it.
For medical professionals involved with clinical development of drugs and medical
devices, they are well educated that the Food and Drug Administration (FDA) is the
regulating agency that provides the regulatory requirements necessary for final approval.
Additionally, medical devices intended for clinical diagnostic use and the FDA also
actively regulates diagnostic kits, which are intended for the same clinical use. In contrast
however, Research Use Only (RUOs) products are unregulated. Research Use Only
products are often discussed as medical devices but they are not devices but an
important commercial class of products.
Although unregulated, RUOs are mentioned briefly in 21 Code of Federal Regulations.
For the past 30 years, these important commercial products, used in both basic and
Register Now

2. clinical laboratories, have been the subject of intense discussion on how to regulate their
distribution and used for the appropriate laboratory use.
One of the confusing points of discussion has been the name used as labels for these
products. Some manufacturers label them “research use only”, others use investigational
use devices (IVD) while others use investigational use only (IUO). With technology and
innovation directing the development of drug products for unmet medical needs, the age
of molecular diagnostics is very much a part of the clinical research industry.
Therefore it is increasingly important to provide a regulatory framework for
manufacturers, marketers and sellers of these products to have guidelines to follow when
approaching the clinical community. Ultimately, Congress will have to provide the
amendment to the Food, Drug and Cosmetic Act that will provide that regulatory
framework for an important commercial product in clinical development.
Why should you attend?
This webinar is an important first step for both professionals, both marketing and sales, to
take as they promote and distribute Research Use Only (RUOs) for use by medical
professional in clinical laboratories and investigational ones as well. RUOs are important
commercially available products that have been in both basic and clinical laboratories.
With the constant change in technology in both medical devices and products used in the
clinical diagnosis of diseases, marketing professionals need to have knowledge as to the
regulation requirements for their specific products.
Many of the RUOs are used clinically to determine the appropriate treatment regimens to
use to therapeutically resolve these medical issues.
Participates will be navigated on a chronological path of FDA attempts to regulate
Research Use Only products, a path that has spanned 30 years with an increasing focus
towards regulatory requirement in the past 3 years.
Areas covered in the webinar
Research Use Only (RUOs) has and plays a significant role in clinical development
including the drug development process – clinical trials. Although unregulated by the
FDA, attendees will learn about the Code of Federal Regulations which plays a major
role in the regulatory and labeling requirements of RUOs that both manufactures and
sales representative need to be aware of.
This webinar will also discuss the several Guidance Documents issued by the FDA in
attempts to regulate RUOs and the lack by the agency to enforce the regulations outlined
in them. Current thoughts and positions of the FDA to regulate will be discussed with
special attention to “letters written by member of Congress sent to Congressional
Committee” and a Bill introduced in 2013 which if enacted will change the landscape of
RUOs for the future.
Learning objective

3. • Definitions of Research Use Only – what are RUOs?
• Code of Federal Regulations for Research Use Only Products
• Guidance Documents Issued by the FDA
• Labeling Requirements for RUOs
• Good Manufacturing Practices
• Letter from Members of Congress to the Commissioner of the FDA
• Congressional Bill regarding FDA’s Authority for Research Use Only Products
Who will benefit
• Preclinical Researchers
• Clinical Researchers
• Sales and Marketing Staff Personnel
• Laboratory Compliance Office
• Biotechnology and Pharmaceutical Professionals
• Risk/Compliance Officers in the Clinical fields
• Good Manufacturing Practice Managers
Speaker profile
Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both
academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s
research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension,
Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical
antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety
to provide safer medicines to patients was a priority.
Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular
Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team.
Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in
biology and is a member of The Safety Pharmacology Society.
During his prestigious career, Harold Thibodeaux’s ambition and innovation resulted in the successful
clinical development of several novel drugs. As a young scientist with Genentech, his contributions to
the Second Generation TPA Project were rewarded with the FDA approval of a thrombolytic drug (TNK-
TPA or Tenectaplase) that was indicated for Acute Myocardial Infarction. Another notable achievement
with the same project team was the approval of Activase Alterplase for Acute Ischemic Stroke
Treatment.
As a scientist at Theravance, his innovative models of cardiovascular safety were instrumental in the
formation of a Theravance/GlaxoSmithKline Partnership and the development of two clinical candidates
for Chronic Obstructive Pulmonary Disease (COPD). Both drugs, BREO Ellipta and ANORO Ellipta,
were approved by the FDA and are currently providing therapeutic benefits with patients with COPD. In
his role as an investigative scientist with Stiefel, a GlaxoSmithKline Company, Mr. Thibodeaux explored
new medical research paths and using his many years of experience in the industry to support project
efforts for the reformulations of topical antibiotics, development of models to study acne and writing
protocols psoriasis.
For more information, contact support @complianceglobal.us