Understanding the Regulatory Requirements for the Over the Counter (OTC) Drugs in the US
Recorded Audio Conference | David Lim | From: Aug 01, 2017 - To: Sep 30, 2017
All drugs are reviewed and approved by the the FDA’s Center for Drug Evaluation and Research (CDER) before they can be consumed and used for human treatments. In as much as prescription drugs undergo heavy scrutiny, the same goes for over-the-counter drugs also known as non-prescription drugs.
In order to introduce OTC drugs within the US market, there is need for deep understanding of the rules and regulations that govern drug production. This webinar conference is designed to help you develop a complete understanding of how OTC nonprescription drugs are developed and brought into the US market.
Area covered in the session :
All laws and regulation pathways that regulate and govern OTC drugs in the US
Key points in OTC drug development
Requirements for OTC drug approval and consideration
FDA actions during drug review
FDA and FTC jurisdictions
Recommendations for successful drug approval
Who will benefit ?
CEO and managers
Drug regulators and developers
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