Winning Product Submissions - Find Out What the FDA Is Looking for & How to Get Your Product Approved Sooner
The teleconference event Winning Product Subsmissions--Find Out What the FDA is Looking For and How to Get Your Product Approved Sooner will be held on Tuesday, April 24, 2007 from 11 a.m. to 12:30 p.m. PST. The audioconference will address the following:
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The importance and underlying principles of the FDA drug development process from Phase I through market approval;
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How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;
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What information about your new product should and should not be included in application packets;
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How to effectively prepare for, and communicate during, meetings with the FDA;
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The common pitfalls that lead to delays and non-approvable determinations ;
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How to maintain investor confidence throughout the review process;
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An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];
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Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;
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Tips on the submission process — strategies for filing and how to avoid delays;
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The review process and related correspondence; and
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What's new in compliance guidance documents.