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FDA’s Policy On Communicating Drug Approval Information




FDA’s has made effective manual procedure and policy for communicating drug approval information. Considering interest of industry and FDA including press an other international counter parts FDA will make drug approval information (Approval Letter) available on CDER’s website.

In the  published  manual of FDA  it is mentioned  that,   approval and tentative approval letters for original and supplemental drug  applications will be made available through  CDER’s Web site, generally within three  business days of the approval, for the following categories:
1) NDAs and BLAs (Original application,  efficacy supplement labeling supplements )
2) ANDAs identified by the Office of Generic Drugs (OGD)

Labeling information of approved ANDA (RLD only), NDA and BLA  will be published to CDER’s website  within three days of   approval of labeling supplement.

You can find manual at below link

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