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Prescription Drug Submissions - Submission of NDA and NDA Review Classifications

SUBMISSION OF THE NDA AND NDA REVIEW CLASSIFICATION

ELECTRONIC SUBMISSIONS

  • Are submitted either on CD or DVD or through the FDA’s electronic submissions gateway (ESG)
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Prescription Drug Submissions

Prescription Drug Submissions - CTD and eCTD

COMMON TECHNICAL DOCUMENT (CDT) and ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) FORMAT

INTRODUCTION
  • A marketing application such as an NDA contains voluminous information and data. For the most part, the same information is required in every country where the sponsor plans to market the drug…
  • 199 more words
Prescription Drug Submissions

New Guidelines for a Critique Serivce

There is a $5.00 fee for the critique of your submission(s). 

BOOK-LENGTH WORKS: Fiction & Nonfiction
Each of the following categories has the same submission… 250 more words

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