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8th November 2012, 01:51 PM
Super Moderator
 
Join Date: May 2012
Re: FDA NDA Annual Report

As you are looking for the annual report of FDA NDA so we are providing you the annual report of it.

Major Changes in Annual report :
Changes based on postmarketing study results, including, but not limited to, labeling changes associated with new indications and usage.
Change in, or addition of, pharmacoeconomic claims based on clinical studies.
Changes to the clinical pharmacology or the clinical study section reflecting new or modified data.
Changes based on data from preclinical studies.




For more detail about the annual report we are providing you a PDF file with it so you can get more details about it .
Attached Files
File Type: pdf FDA NDA annual report guidance .pdf (177.8 KB, 92 views)


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