Research Use Only Products - The Dos and Don'ts
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 clinical laboratories, have been the subject of intense discussion on how to regulate their distribution and used for the appropriate laboratory use.
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.
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. All of the information in this webinar will be summarized to provide the manufacturers, marketing, sales and medical personnel with the information to determine the "dos and don'ts of selling RUOs in a clinical environment".
Areas Covered in the Session:
- 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
- 2013 Congressional Bill regarding FDA's Authority for Research Use Only Products
Who Will Benefit:
- Regulatory Compliance Associates and Managers
- Marketing Staff
- Basic and Clinical Sales Representatives
- Administrative Managers in charge of Clinical Research
- Clinical Laboratory Managers
- Basic Science Laboratory Managers
- Procurements Officers
- Medical Device Distributors
- Clinical Research Organizations
- Manufacturers of Medical Devices and Clinical Supplies
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.
During his years of academia and pharmaceutical industry provided an opportunity to authored 23 published articles and discussed his work with poster presentation at major scientific meetings. Harold is proud to have been a medical researcher in both academia and the biopharmaceutical industry and continues to support projects that lead to strategic partnerships that will develop novel drug pipelines for unmet medical needs and present webinars and seminars on drug development to assist pharmaceutical companies achieve their goals.