Guidebook for Drug Regulatory Submissions

Destined to become every regulatory director's essential desktop companion

Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.

Demystifying this complex, high-stakes process, author and nationally recogn...