FDA Regulations for OTC Drugs
Duration : 90 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
OTC drugs comprise approximately 60% of all medicines sold in the United States. Once these products are found safe for use without the supervision of a physician by the Food and Drug Administration (FDA), they are available to consumers in their local drugstores or supermarkets. However, the system by which OTC drugs are regulated is outdated, putting consumer health at risk and hindering innovation that can benefit consumers. Over-the-counter (OTC) drugs are routinely used to treat a wide variety of illnesses ranging from headaches to bad breath. It proposes key reforms to the regulatory system that oversees the majority of OTC medicines – the OTC Monograph system.The Over-the-Counter Drug Safety, Innovation, and Reform Act of 2017 seeks to modernize the system to better serve the American public.
In this webinar join expert speaker Joy L. Mcelroy, where she will discuss that how the public is more rapidly protected in the event of safety issues.
Course Objectives:
Those who work in the OTC drug field need to understand how this Act will help companies introduce new and innovative products. After attending this webinar, you’ll be better prepared to introduce new and innovative OTC drug products for marketing and sale in the United States, while mitigating the risk of FDA enforcement action in the future.
Course Outline:
• Learn how the Act reforms the monograph process to an administrative order process (the same legal authority used for other medical product approvals).
• Learn how processes are established by this act for manufacturers to request administrative orders, or for the Secretary to initiate administrative orders at the recommendation of the FDA or in response to citizens’ petitions.
• Learn what processes are in place by which drug developers can request meetings with FDA, similar to existing processes for prescription drug development.
• Learn the requirements for an annual update to Congress on FDA’s evaluation of the cold and cough monograph with respect to children under the age of 6.
• Learn how the act authorizes the FDA to collect user fees so that the agency has the necessary resources to evaluate and monitor the OTC market.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• QA managers and personnel
• Quality control unit directors and staff
• Regulatory Affairs personnel
• Manufacturing Managers and Supervisors
• Consultants
• R&D managers
• Directors and Associates
• Legal representatives
• Consumer healthcare professionals
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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