How to Get FDA
Drug Approval 
Complete Guide

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

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How to Get FDA Drug Approval