Generic Drug Approvals - Preparing an ANDA for First-Cycle Approval

This three-day course is directed towards and geared for those who assemble, supervise, or manage the preparation and submission of Abbreviated New Drug Applications (ANDAs). The course is suitable for professionals in regulatory, analytical, quality, development and manufacturing groups. The course will also benefit those in other departments who are required to provide information to be incorporated into submission documents.

Learning Objectives

Upon completion of this course you will have a clear understanding of regulatory agency expectations and will have gained the background knowledge necessary to effectively plan, gather required documentation and assemble an ANDA. You will have learned how to organize your company and develop timelines to assure that the ANDA is filed on time. You will have gained practical knowledge regarding the development of templates and checklists to assure completeness of the application. You will have gained the information necessary to prepare the ANDA in either paper or electronic format for final submission.

Course Description

This course provides comprehensive and up-to-date knowledge of the preparation of an Abbreviated New Drug Application (ANDA) to the U.S. FDA Office of Generic Drugs. The course covers regulatory expectations regarding the format and content as described in FDA regulations and guidelines. The course will focus on the preparation of a paper-based submission but also give instruction on how to convert it to an electronic submission. In addition, due to the small class size, there will be time to address specific issues and questions of individual participants.

Time is money -- avoidance of costly and time-consuming clinical trials is, therefore, quite desirable for drug companies in the race to bring products to the marketplace before competition. A 505(b)(2) application might offer an appealing regulatory pathway alternative. This route permits companies to obtain FDA approval of new drug applications (NDAs) by relying, in part, on the Agency's findings for a previously approved drug. Created in 1984 as part of Hatch-Waxman, the 505(b)(2) application is intended to encourage sponsors to develop innovative medicines using currently available products. According to Section 505(b)(2) guidelines, an NDA approval can be obtained for a new drug without conducting the full complement of safety and efficacy trials and without a "right of reference" from the original applicant. This portion of the course aims to clarify this process and give the participants the knowledge to develop a suitable drug product and prepare a successful 505(b)(2) application.

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COURSE AGENDA

DAY ONE

9:00 – 10:15 A.M.

• Introductions and “How to Use This Course”
• ANDA Regulatory Scheme
• ANDA Organization Overview
• ANDA Project Management

10:30 – 12:00 Noon

• Module 1 - Administrative Information and Prescribing Information Folder

1:00 – 3:00 P.M.

• Module 2 - Summary Folder

3:30 – 5:00 P.M.

• Module 3 - Quality Folder

DAY TWO

9:00 – 10:15 A.M.

• Module 3 - Quality Folder (continued)

10:30 – 12:00 Noon

• Module 3 - Quality Folder (continued)

1:00 – 3:00 P.M.

• Module 5 - Clinical Study Reports Folder
• Cover Letter & Forms
• Review & District Copies

3:30 – 5:00 P.M.

• Electronic Submission
• CTD format

DAY THREE (optional)

9:00 – 10:15 A.M.

• What is a 505(b)(2) application?
• History and regulatory basis of the 505(b)(2) application
• Comparison between 505(b)(2), ANDA and ANDA Suitability Petition
• Benefits of a 505(b)(2) application
• What Types of Products Can Utilize the 505(b)(2) Approval Route?

10:30 – 12:00 Noon

• Where is this approval route not appropriate?
• Current legal challenges to the 505(b)(2) process
• How to determine if your proposed product can be a 505(b)(2)

1:00 – 3:00 P.M.

• Development activities for a 505(b)(2)
• Regulatory steps for a 505(b)(2)
• Resources