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

Added by Referral on 2012-01-05

Conference Dates:

Start Date Start Date: 2012-01-18
Last Date Last Day: 2012-01-18

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

This 3-hr virtual seminar on the FDA New Drug Approval Process will cover 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. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.

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.
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