#1
6th November 2012, 11:03 AM
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FDA NDA Annual Report
Hy Guy’s I am looking for the FDA New Drug Application guidance for Annual Report so please can you give me the some details about it ?
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#2
8th November 2012, 01:51 PM
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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 . |