3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process

Why Should You Attend:

This virtual seminar is intended for Regulatory Affairs Professionals, Managers, Consultants, Scientists and Research Analysts seeking an introduction to the FDA new drug approval process.

This presentation will focus on the new drug application (“NDA”) and the abbreviated new drug application (“ANDA” or “Generic Drug”). The presenter will provide attendees with an overview of the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. Within the context of the approval process, the various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.

Learning Objectives:

• Gain a basic understanding of FDA's NDA requirements and approval requirements.
• Distinguish between a full NDA and a 505(b)(2) NDA, and when they should be used.
• Understand the process for identifying when the filing of an ANDA is appropriate.
• Become familiar with the contents of full NDAs; 505(b)(2) NDAs and ANDAs; and the process for filing such application.
• Understand the timing and costs involved with filing an NDA, a 505(b)(2) NDA and an ANDA.
• Obtain a basic understanding of User Fees, Fee Waivers and Marketing Exclusivity.

Areas Covered in the Seminar:

• FDA's various NDA review and approval pathways.
• FDA's ANDA or Generic Drug review and approval process.
• The difference between a “full” NDA and a 505(b)(2) NDA and an ANDA.
• The various elements of a full NDA, 505(b)(2) NDA and ANDA.
• When and how often it is necessary to meet with FDA during the review and approval process.
• The costs involved with filing a drug application included required User Fees and options for obtaining Fee Waivers or Reductions.
• An introduction to the differences between Phase I, Phase II and Phase III clinical testing.
• An overview of FDA approval times and rates.
• Options for Marketing Exclusivity.
• Strategies for success and efficiency.

Who Will Benefit:

• Regulatory Affairs Professionals
• Managers
• Consultants
• Scientists
• Research Analysts
• State Policy Officials
• Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists
• Pharmaceutical and Biotech Companies
• Start-ups
• Drug Producers
• Foreign Manufacturers
• Importers
• Drug Labelers
• Pharmacists
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

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