Jackets for NDA (New Drug Applications) submissions - FDA Guidance

[Tuckee]

Hi All:

I have noticed that the FDA Guidance on Formatting, Assembling and Submitting New Drug and Antibiotic Applications states that applicants may request supplies of required submission jackets from the FDA in writing. However, this guidance is quite old, and I want to ensure that these supplies are still available to applicants. Does anyone know if industry may still request free submission jackets from the FDA?

Thanks very much!
J. Tucker

 

[Stijloor]

Hi All:

I have noticed that the FDA Guidance on Formatting, Assembling and Submitting New Drug and Antibiotic Applications states that applicants may request supplies of required submission jackets from the FDA in writing. However, this guidance is quite old, and I want to ensure that these supplies are still available to applicants. Does anyone know if industry may still request free submission jackets from the FDA?

Thanks very much!
J. Tucker

Can someone help?

Thank you.

Stijloor.

 

[Tuckee]

I was finally able to locate an answer to my question on the FDA's website. Thanks anyway!