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Guideline on Formatting, Assembling, & Submitting New Drug & Antibiotic Applications
Guideline on Formatting, Assembling, & Submitting New Drug & Antibiotic Applications
 
Our Price: $20.00
Year: 1987
Pages: 66
Binding Paperback

Product Code: 0788147846

Description
 
Barry Leonard (ed). The provisions of the Federal Food, Drug, & Cosmetic Act state that a new drug may not be introduced or delivered for introduction into interstate commerce unless the FDA has approved a new drug application (NDA) for it. This guide provides detailed instructions for submitting these applications. Includes instructions on copies needed, jackets, paper size & binding, volume size & identification, pagination, packaging, amendments & post-marketing reports, & application content. Discusses an acceptable format for preparing a well-structured & unified summary for submission in an application.

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