Winning Product Submissions – Find Out What the FDA Is Looking for & How to Get Your Product Approved Sooner

Written by on Sunday, April 8th, 2007

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:

  • The importance and underlying principles of the FDA drug development process from Phase I through market approval;

  • How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;

  • What information about your new product should and should not be included in application packets;

  • How to effectively prepare for, and communicate during, meetings with the FDA;

  • The common pitfalls that lead to delays and non-approvable determinations ;

  • How to maintain investor confidence throughout the review process;

  • An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];

  • Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;

  • Tips on the submission process — strategies for filing and how to avoid delays;

  • The review process and related correspondence;  and

  • What’s new in compliance guidance documents.

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