Ctd vs nda

I am preparing for NDA Requirement-2015. Now I am selected in CTD Requirement-2014 but I am interesting in NDA (National Academy of Defense). Please tell me which is best option between CTD and NDA?

Hii Buddy , I want to know List of Common Technical Document includes New Drug Application Will you please Provide me Details about Same ?

[Shaleen]

The NDA is the Vehicle through Which Drug Sponsors (Pharma Companies) formally Propose that the FDA Approve a new pharmaceutical for sale and marketing in the U.S.

In simple terms “It is an application filed with USFDA to get approval for marketing a new pharmaceutical for sale in the U.S.”

Drug Approval is the Goal of the Long Process of Drug Development.

The Common Technical Document: The Changing Face of the New Drug Application

Format and Content of NDA :

The FDA Recommends ICH’s CTD for filing the NDA.

Documents in each Module-

Administrative and prescribing information (region specific)
Summaries and overview
Information on product quality
Nonclinical study reports
Clinical study reports

Module 2 – Common Technical Document Summaries

Module 2 should Include the Summary Documents.

The Documents for this Module Should be Provided in the Order as Described Below.

Overall CTD table of contents
For the first document in this module, a comprehensive table of Contents should be provided listing all of the documents provided in the submission for modules 2 through

Introduction to the summary documents
Introduction to the summary should be provided as described in the guidance document M4: Organization of the CTD as a one page document.

Overviews and summaries
Module 2 should contain the following additional documents as described in the appropriate guidance documents (M4Q: The CTD -Quality, M4S:The CTD - Safety, M4E: The CTD – Efficacy):

Quality overall summary (2.3, Module 2, section 3)
Non clinical overview (2.4)
Clinical overview (2.5)
Nonclinical summary (2.6)
Clinical summary (2.7)

The nonclinical summary and the clinical summary should be provided in separate volumes for ease of use by reviewers.


Here I m a Attaching pdf File Which having complete In formation about Submitting Marketing Applications According to the ICH/CTD Format You Can Download free of cost :