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 Give Corrective Feedback: The CARE Model - Eliminati…
Why EBITDA Doesn't Spell Cash Flow and What Does
SOPs - How to Write Them to Satisfy those Inspectors
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Documenting Misconduct that Will Stand Up in Court
Marketing to Medicare or Medicaid Beneficiaries - What You …
Tattoos, hijabs, piercings, and pink hair: The challenges …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Project Management for Non-Project Managers - How to commun…
Female to Female Hostility @Workplace: All you Need to Know
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Sunshine Act Reporting - Clarification for Clinical Research
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Understanding the Artificial Intelligence Landscape
Establishing Appropriate Quality Metrics and Key Performanc…
Holiday Stress and Loss: The Art of Stress Resilience in E…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Is Your Culture Working For or Against Your Success? If You…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Red flags that can render your OSHA Safety Program Complete…
Onboarding is NOT Orientation - How to Improve the New Empl…
The Anti-Kickback Statute: Enforcement and Recent Updates
How to Prepare For and Host a FDA Inspection and Respond to…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …