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.
Understanding and Analyzing Financial Statements
Onboarding is Not Orientation: How to Improve Your New Hire…
Managing Toxic & Other Employees Who have Attitude Issues
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel & ChatGPT Synergy Masterclass: Unleashing Financial A…
Introduction to Microsoft Power BI Dashboards
Drive Recruiting Success with the Using Recruiting Metrics …
2025 EEOC & Employers: Investigating Claims of Harassment …
Impact Assessments For Supplier Change Notices
Mastering Job Descriptions: Legal and Practical Insights fo…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
What is in Store for Employers When Updating Employee Handb…
Designing Employee Experiences to Build a Culture of Compli…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Accounting For Non Accountants : Debit, Credits And Financi…
Creating a Successful Job Rotation Program
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Compliance And Laboratory Computer System Validation
How To Create Psychological Safety in your Organization
Aligning Your HR Strategy with Your Business Strategy
Transforming Anger And Conflict Into Collaborative Problem …
How to Give Corrective Feedback: The CARE Model - Eliminati…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Zero Acceptance Sampling to Reduce Inspection Costs
Identifying, Managing, and Retaining High Potential Employe…
AI at Your Service: Enhancing Your Microsoft OfficeSkills w…
Why EBITDA Doesn't Spell Cash Flow and What Does
FDA Recommendations for Artificial Intelligence/Machine Lea…
Project Management for Non-Project Managers - How to commun…
Dealing With Difficult People In Life & Work
Developing and Implementing Quality Culture in the Organiza…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Enhancing Pivot Tables with Images: Visualize Your Data Lik…
How to Write Effective Audit Observations: The Principles f…
How to Write Contracts for Procurement Professionals
Uplifting the Credibility of HR: How to Build the Credibili…
Strategic Interviewing & Selection: Getting the Right Talen…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
FDA Audit Best Practices - Do's and Don'ts
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …