Achieving ANDA Success Working with the FDA to Win First-Cycle Approval
Are you hoping for a one cycle approval of your ANDA?
This report explains how to meet the challenges and avoid the pitfalls in pursuing first-cycle ANDA approval including:
Advice on how to approach the FDA for guidance before you file your ANDA
How to work with Drug Master File holders and API suppliers to make the ANDA process go smoothly
Order your copy of Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval today — applicants who get it right the first time can get their products to market quicker.
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PDF Edition — $397
Who Will Benefit
Generic drug manufacturers
Submission and applications specialist
Strategic planning and lifecycle management specialists
Personnel new to the industry
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