This wiki has undergone a migration to Confluence found Here
<meta name="googlebot" content="noindex">

Difference between revisions of "Pre-submission"

From HL7Wiki
Jump to navigation Jump to search
 
Line 5: Line 5:
  
 
==External Links==
 
==External Links==
[http://www.fda.gov/cder/regulatory/ersr/Module1Spec.pdf Official ICH Website]
+
[http://www.fda.gov/cder/regulatory/ersr/Module1Spec.pdf FDA's M1 eCTD Specification]
  
 
[[Category:RPS Glossary]]
 
[[Category:RPS Glossary]]

Latest revision as of 14:46, 29 September 2008

Information submitted prior to the submission of a complete new application.

Additional Regional Definitions and Synonyms

None

External Links

FDA's M1 eCTD Specification