modernizing-fdas-regulation-of-over-the-counter-drugs

Modernizing FDA's Regulation of Over-the-Counter Drugs

Live Webinar

  • 90 minutes

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. 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 However, the system by which OTC drugs are regulated is outdated, putting consumer health at risk and hindering innovation that can benefit consumers. 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 Mcelroy, where she will discuss that how the public is more rapidly protected in the event of safety issues.

Session Highlights:

  • 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.

Why You Should Attend:

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.

Who Should Attend:

  • 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


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Joy Mcelroy

Joy Mcelroy

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Joy work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 she moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, she moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 14 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, she has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing.

She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. She develops and delivers webinars, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more. Joy also writes articles on these topics for various online magazines.In 2013 she started my own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

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