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Ref : 31862
Event :FDA Regulations for Commercializing OTC Drug Products

Date :Thursday May 28th, 2020

Location :Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.

Objectives

  • Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
  • Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
  • Recognize the difference between the various pathways for commercializing an OTC Drug Product.
  • Understand how to identify and successfully navigate an OTC Drug Monograph.
  • Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
  • Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations.
  • Identify the required elements of a compliant OTC Drug Label.
  • Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
  • Possess a working knowledge of the Rx-to-OTC Switch Process.
  • Review and evaluate several of FDA’s current OTC Monographs with a focus on the Cold & Cough and Oral Healthcare monographs.


 

Program

  • Do you know how to properly market and sell an OTC drug in the U.S.?
  • Are the ingredients in your product safe? Does your label comply with the regulations?
  • If you are already selling OTC drugs, are you ready for an FDA facility inspection?


 

Speakers

Karl Nobert, Esq. is an FDA Regulatory Attorney with the law firm of Michael Best in their Washington, DC office.

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics vitamins and dietary supplements; and veterinary products. He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Karl has significant experience in the areas of understanding FDA product detentions and developing strategic solutions for the removal of companies and products from Import Alerts. He has successfully assisted multiple clients with resolving costly detention issues including a large Canadian food company with multi-national operations, several Japanese drug and ingredient manufacturers, a European beverage maker, an Israel-based pharmaceutical distributor and a start-up pet product company.


 

Organizing committee

ComplianceOnline
 

Location

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Conference address :
Palo Alto
United States
Map and directions

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Details

FDA Regulations for Commercializing OTC Drug Products Pharmacy
otc drug, over-the-counter drugs, otc drug product marketing, otc drug product regulation, otc drug monograph, fda otc drug requirements, fda guidelines for otc drugs, otc drug overview
Professionals
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