The templates we use have the following headings for Module 2.2:
- name
- active ingredients
- pharmacological class
- structural formula
- formulation of the dosage form
- route of administration
I've seen others that include (in addition to the above list) an introductory statement, a brief summary of human experience, and identification of countries where the drug has been withdrawn/rejected.
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Marissa Berry, Ph.D., RAC
Manager, Global Regulatory Affairs
Cary, NC
United States
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Original Message:
Sent: 29-May-2019 20:58
From: Anonymous Member
Subject: overall summary (Module 2.2) for an NDA
This message was posted by a user wishing to remain anonymous
Does anyone have a template or an example for an overall summary (Module 2.2) for an NDA? I will appreciate any help I don't have the regulatory background and the objective of this exercise is for a College Project.