This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
The Food and Drug Administration and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The U.S. Food and Drug Administration's (FDA) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 4 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (NDA); (c) via the currently popular Rx-to-OTC Switch Process or (d) via an ANDA citing a previously-approved product.
This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product. FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.
This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product. FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.
Dr. Loren Gelber
Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has prepared more than 50 submissions to the FDA. Her specialty is compliance with US regulatory requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.
The Importance of the first 5 seconds when presenting
Project Management for administrative professionals
How to Reduce Human Error in a GMP Manufacturing Floor
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Launch Your Career: The Ultimate Guide for Emerging Profess…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Managing Toxic & Other Employees Who Have Attitude Issues
Data Integrity – In compliance with CSA, 21 CFR Part 11, Sa…
Effectively Handle Toxic People for Better Productivity and…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Employee Handbooks: 2025 Critical Issues
Better Business Writing-How to Write Right
The five qualities every successful leader must develop
How to Lead and Manage a Narcissistic Employee
Use of AI and GPT for Finance Professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Analytical Method Validation Under Good Laboratory Practic…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel What-If-Analysis Decision-Making Tools
How to Write Contracts for Procurement Professionals
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People: At Work & In Life
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Retention Starts Here: Stop Losing Your Critical Talent and…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
AI and Human Resources: The Great Opportunity!
Cyber Security Incident Response Team Training Program
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI