<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=489233&amp;fmt=gif">
  • Book your Demo

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
ipad-fda-1
FDA-guide-info01-all

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