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This book will bring you up to speed on recent changes to the NDA process — including the change from paper to electronic format — and guide you step-by-step through the application process. Whether you’re an industry veteran or newcomer, this book will help ensure that your new drug does indeed makeit to the marketplace.
Your NDA sets out the conditions that can spell the difference between commercial success and failure. In Preparing the New Drug Application, you’ll get comprehensive guidance on how to:
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