3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity

This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.

Why Should You Attend:

Almost everyone who markets and sells an FDA regulated product in the United States is required to register their facility or establishment, list their products, or both. This includes companies selling human and veterinary drugs, biologics, medical devices, foods and tobacco companies. This session will examine who must register their facilities and list their products with FDA; and how to do so.

The Prescription Drug User Fee Act commonly referred to as “PDUFA”, and The Animal Drug User Fee Act commonly referred to as “ADUFA”, authorizes FDA to collect fees from various companies that produce certain human drug and biological products; and veterinary drug products. During the course of this virtual seminar, attendees will be introduced to FDA’s assessed User Fees and when they apply. It will also discuss when and how such fees must be paid to FDA.

FDA also provides companies with several different types of Fee Waivers and Fee Reductions to lessen the financial impact on certain qualifying companies. The session will explore the fee waivers and fee reductions available to a company for each of the product specific categories; and will describe the criteria and process required for obtaining them.

There are several types of Marketing Exclusivity available to a company seeking to market and sell its products in the U.S. The presenter will discuss each of the available types of marketing exclusivity, their criteria, when they apply and their ultimate impact in the market.

Learning Objectives:

• Gain a basic understanding of FDA’s Establishment Registration and Product Listing Requirements
• Learn who is required to register their facility with FDA including the new food facility registration requirements under the Food Safety & Modernization Act
• Be able to identify when a certain regulated product must be listed with FDA
• Be able to confidently discuss FDA’s User Fee Requirements and the different available options for Fee Waivers & Fee Reductions
• Become familiar with when a company is eligible for an available Fee Waiver and the process for securing it
• Understand what Fee Waivers and Fee Reductions apply to human drugs and biological, medical devices, and veterinary drug products
• Develop ease in identifying the various types of Marketing Exclusivity available, and when and to what products they apply
• Understand the difference between Orphan Drug, New Chemical Entity, New Indication, 180-Day Generic Drug and Pediatric. Marketing Exclusivity
• Develop an understanding of and be able to discuss the Patent Term Restoration Program and how it works

Areas Covered in the Webinar:

• Establishment Registration and Product Listing
• Drug, Biologic, Medical Device and Veterinary Drug User Fees
• Fee Waivers including human and veterinary Sponsorship and Application Fees
• FDA’s Small Business Medical Device Fee Reduction Program
• The Significant Barrier to Innovation Fee Waiver
• Orphan Drug Exclusivity
• New Chemical Entity Exclusivity or “NCE”
• 505(b)(2) or New Approved Indication Exclusivity
• 180-Day Generic Drug Exclusivity
• Pediatric Exclusivity
• Patent Term Restoration

Who will Benefit:

• Pharmaceutical, Biologics, Animal Health, Food, Tobacco, Medical Device and Biotech Companies
• Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists
• Senior Management
• Documentation
• Domestic and Foreign Corporations, Small Business, Start-Up Ventures, Manufacturers, Importers, - Labelers and Product Distributors
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a Food and Drug Regulatory Attorney in Washington, DC. He regularly provides FDA regulatory advice and counseling to domestic and international pharmaceutical, medical device, OTC drug, medical devices and veterinary drug companies. He advises his clients on issues related to the FDA’s regulation of their products and provides them with strategic recommendations for regulatory compliance and mitigating potential enforcement risk. He frequently presents and has published on such topics.