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.
Female to Female Hostility @Workplace: All you Need to Know
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Understanding Artificial Intelligence (AI) & using Chat GPT
Creating Loyal Customers Through Excellent Customer Service
Understanding and Communication New Immigration Policies (2…
Navigating Talent Management and Retention Strategies.
HIPAA is Unsettled – Safe Compliance Strategies
Project Management for Non-Project Managers - Scheduling yo…
How to Prepare For and Host a FDA Inspection and Respond to…
Empowering Conflict Resolution: Letting Go to Gain Control
Onboarding Best Practices for 2025: Proven Strategies to Po…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Toxic Employees: Strategies For Leaders To Effecti…
How to Conduct Exit Interviews - Implementing and Enhancing…
Adapting to Change: Strategies for Personal & Team Resilien…
Introduction to Excels Built-In Solver – Advanced Decision-…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Design Control for Medical Devices Including Verification/V…
Stress, Change And Team Resilience Through Humor: An Intera…
Developing and Implementing Quality Culture in the Organiza…
GROUPBY and PIVOTBY functions. Pivot table killers?
Negotiating Skills For Professional Results - Winning Strat…
Use the power of AI to turbocharge your MS Excel
Trust in Leadership: Building and Maintaining Trust as a Le…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
AI and Human Resources: The Great Opportunity!
Tools and Tactics for Grieving, Surviving, and Thriving in …
Bootcamp for New Managers and Supervisors: Develop These Es…
How To Conduct An Internal Harassment And Bullying Investig…
How Generative AI can be used in Banking Risk and Compliance
Creating Employee Handbooks that Protect You and Support th…
Excel Power Skills: Master Functions, Formulas, and Macros …
Emotional Intelligence: Mastering the Emotions of Great Lea…
Managing Toxic & Other Employees Who Have Attitude Issues
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
SOPs - How to Write Them to Satisfy those Inspectors
Improving Employee Engagement & Retention Through Stay Inte…
How to Give Corrective Feedback: The CARE Model - Eliminati…