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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! 

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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