FDA Regulation of OTC Drugs in the USA

Event Information
Product Format
Prerecorded Event
Conference Date
Fri, Feb 24, 2017
60 minutes
Product Description

Understand the FDA Regulations and Labeling Requirements of OTC Drugs.

To market Over-the-counter (OTC) drugs in the U.S., it is essential to understand the regulations and labeling requirements of the Food and Drug Administration (FDA). Understanding FDA’s regulations and the labeling requirements of the OTC monograph system will not only help assure compliance, but will also enable those who want to market U.S. products to make optimal label claims and avoid FDA issues and Warning letters.

Join this session by expert speaker, Norma Skolnik, to understand the concepts regarding U.S. OTC Drug labeling requirements. She will also discuss OTC Drug Monographs and their importance to Drug Labeling compliance.

Session Highlights

  • U.S. OTC Drug labeling requirements
  • OTC Drug Monographs and their importance to Drug Labeling compliance
  • FDA Drug Facts Labeling regulations
  • How to Use the OTC Monographs to achieve the best product labeling?
  • FDA Adverse Event Reporting requirements for OTC Drugs

Bonus Resources:

  • Citations to all relevant FDA regulations
  • Relevant FDA website references
  • Know-how tips on marketing OTC drugs in compliance with FDA requirements

Who Should Attend

Regulatory Affairs managers and associates, QA mangers, OTC Drug Marketing managers, and anyone interested in learning about U. S. OTC Drug labeling requirements

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

You can also order through:




About Our Speaker

Norma Skolnik - FDA Regulations Expert

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and...   More Info
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus
Audio Educator


Dear Valued Customers


We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


We are no longer able to fulfill online orders. We will fullfill all DVD and book orders already placed.


Customers of canceled webinars and subscription products may request a refund at (800) 223-8720 or service@proedtech.com. You must do so by April 1, 2019.


Thank you for your business and loyalty over the years. We sincerely apologize for any inconvenience caused.


Best regards,

The ProEdTech Team