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    Free Download

    How to Get FDA
    Drug Approval 
    Complete Guide

    Download our guideline and start preparing all your product requirements, development records, and test results documentation to launch your pharamaceutical product in the market fully compliant! 

    Download now
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    What's Inside:

    Step 1:
    Discovery and Development

    01. A Discovery

    01. B Development

     

    Step 2:
    Preclinical Research

    02. A In vitro

    02. B In vivo

     

    Step 3:
    Clinical Research

    03. A Clinical Trial Design

    03. B Clinical Trial Phases

    03. C Investigational New Drug (IND) process

    03. D FDA IND Review Team

    03. E Drug Approval

     

    Step 4:
    FDA Drug Review

    04. A New drug application

    04. B FDA Review

    04. C FDA Approval

    04. D FDA Advisory Committees

     

    Step 5:
    FDA Post Market Drug Safety Monitoring

    05. A Supplemental Application

    05. B INDs for marketed drugs

    05. C Manufacturer inspections

    05. D Drug advertising

    05. E Generic drugs

    05. F Reporting problems

    05. G Active surveillance

    05. H Adverse event reporting

     

    Complete your download by reading:

    How to Get FDA Drug Approval