Understanding The Regulation of Prescription Drugs


The FDA and the Consumer Product Safety Commission have regulations pertaining to drugs. The FDA is responsible for the regulation and oversight of the U.S. drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of 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 505(b) NDA, 505(b)(1) NDA, 505(b)(2) NDA and ANDA.

This webinar will provide attendees with an overview of the knowledge and skills needed to develop and produce a prescription (Rx) drug product

Course Objectives:

• Gain an understanding of how Rx drug products are regulated in the U.S.
• Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
• Understand the difference between the various pathways for commercializing an Rx drug product.
• Know the required elements of a compliant Rx Drug Label and Insert.
• Understand strategies for marketing and promoting Rx drug products, and for mitigating potential enforcement risks.
• Learn the Rx-to-OTC Switch Process.
• Review and evaluate several of FDA’s Warning Letters

Why Should You Attend:

This webinar will discuss U.S. Food and Drug Administration (FDA) regulation of Rx drug products and mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available strategies for producing and selling an Rx drug product.

Course Outline:

• Gain an understanding of how Rx drug products are regulated in the U.S.
• Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
• Understand the difference between the various pathways for commercializing an Rx drug product.
• Know the required elements of a compliant Rx Drug Label and Insert.
• Understand strategies for marketing and promoting Rx drug products, and for mitigating potential enforcement risks.
• Learn the Rx-to-OTC Switch Process.
• Review and evaluate several of FDA’s Warning Letters

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Regulatory affairs managers, directors and associates
• Compliance specialists
• Marketing managers
• Quality professionals
• Document control specialists
• Record retention specialists

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 been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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