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#42: Fundamentals of ANDA Submissions and FDA Expectations Under GDUFA

Tutorial name:
#42: Fundamentals of ANDA Submissions and FDA Expectations Under GDUFA

Day & Time:
June 14, 9:00AM - 5:00PM

Room Number:

Maximize your learning while attending the DIA 2015 51st Annual Meeting! Receive $100 off of your DIA 2015 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.

There have been significant changes in FDA expectations of Abbreviated New Drug Applications (ANDAs) since the passage of the Generic Drug User Fee Act (GDUFA) in 2012. In this tutorial participants will learn about FDA regulations and expectations for the content, submission, and review of ANDAs and the importance of regulatory strategy in the age of GDUFA. The ANDA format and technical submission requirements, FDA expectations, fees, timelines under GDUFA, and the nuances of ANDA strategy for the regulatory professional including patent certification, and exclusivity periods will be discussed. The tutorial will also focus on suitability petitions and the 505 (b)(2) NDA as a strategy option.

What You Will Learn
• Fundamentals of the Abbreviated New Drug Application (ANDA)
    o Preparation
    o Content
    o Strategy
• Submission expectations and content under GDUFA
    o Chemistry, manufacturing and controls
    o Bioequivalence
    o Drug master files
• Fees and FDA review timelines under GDUFA

• Overview of therapeutic ratings, patent certification, 180-day exclusivity

• What is a suitability petition and when to submit one

• When does a “generic-like” drug become a 505 (b)(2) NDA

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Explain the importance of regulatory strategy for an ANDA;
• Recognize content and format requirements for ANDAs;
• Discuss patent certifications, exclusivity, and therapeutic ratings;
• State ANDA review timelines and FDA expectations under GDUFA;
• Discuss suitability petitions and when to submit;
• Recognize when an application requires a 505(b)(2).

Target Audience:
This tutorial is designed for regulatory affairs professionals new to the ANDA , professionals in quality assurance, quality control, or manufacturing, and project managers.