2016 - Regulatory Requirements for Over-the-Counter (OTC) Drug Products

Description :
The FDA's Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.
To introduce OTC (nonprescription) drug products into the U.S., it is important to accurately understand regulatory requirements applicable for the OTC products including regulatory pathways.
This webinar is intended to help you better understand how OTC nonprescription drugs are developed and brought into the US market.
The speaker will walk you through the regulatory requirements applicable to bring OTC drugs to the market.
Areas Covered in the Session :
Laws and Regulations Governing OTC Drugs and Definitions
Key Considerations for OTC Drug Developments
Regulatory Pathways for OTC Drugs
Best Practices based on Cases
Regulatory Requirements
FDA Review and Regulatory action
Rx-to-OTC Switch
OTC Monographs
OTC labeling and marketing considerations
Critical Considerations
Understanding FDA and FTC Jurisdictions
Recent FDA Approvals of OTC Drugs
PASS-IT Recommendations
Who Will Benefit:
CEOs
VPs
Compliance Officers
Regulatory Affairs Department
OTC Drug Manufacturers
Clinical Affairs Department
Quality Assurance Department
Quality Control Department
Research & Development Department
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA Drug Review and Approval
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/Product...