Regulatory Open Forum

HI All,

I was reading on FDA.gov that from May, 2018- 

• May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.

What does commercial means in this context? and How is it different from IND we submit today?

Thanks in advance for the Responses.

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Rajeev Aneja RAC
Johnson & Johnson
Skillman NJ
United States
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Original Message------

HI All,

I was reading on FDA.gov that from May, 2018- 

• May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.

What does commercial means in this context? and How is it different from IND we submit today?

Thanks in advance for the Responses.

------------------------------
Rajeev Aneja RAC
Johnson & Johnson
Skillman NJ
United States
------------------------------

True.  I would add that the other "categories" of INDs would be those submitted by Investigators or other sponsors such as NIH, neither of which would be considered commercial INDs.

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Glen Park
Scynexis, Inc.
Jersey City NJ
United States
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Original Message:
Sent: 28-Jun-2017 21:33
From: David Lim
Subject: Commercial Investigational New Drug Applications (INDs)

A Commercial IND is an IND for which the sponsor is usually a corporate entity. In addition, CDER may designate other INDs as commercial if it is clear the sponsor intends the product to be commercialized at a later date.