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.
How to Write Contracts for Procurement Professionals
Sunshine Act Reporting - Clarification for Clinical Research
How to Deal with Employees Who Love to Argue and Debate Eve…
Project Management for administrative professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Terminating Toxicity: Strategies For Leaders To Confidently…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Reprogramming your mind for Corporate Excellence: 4 Steps t…
How to Write Effective Audit Observations: The Principles f…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Uplifting the Credibility of HR: How to Build the Credibili…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Bridging Generational Divides in the Workplace
Strategic Interviewing & Selection: Getting the Right Talen…
Onboarding Best Practices for Millennial and All Employees
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
FDA Audit Best Practices - Do's and Don'ts
Emotional Intelligence: Mastering the Emotions of Great Lea…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Accounting For Non Accountants : Debit, Credits And Financi…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Developing and Implementing Quality Culture in the Organiza…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Break Free from Toxicity: Reclaim Your Power and Peace
Tips and Techniques for Conducting an Effective Fraud Risk …
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Navigating 2025 Employment Laws: What Every Employer Needs …
Implementing an Effective Human Error Reduction Program
Cleaning Data without Complex Functions - A Course for Data…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Principles & Practices for the Cybersecurity of Legacy Medi…