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Michael, Librarian
Category: Consumer Electronics
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Experience:  20+ years as information professional
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I am interested in the process of presenting and having approved

Customer Question

I am interested in the process of presenting and having approved a New Drug Application before the FDA. Can you point me toward some sources online that explain the various requirements and how they are satisfied?
Submitted: 2 years ago.
Category: General
Expert:  Michael replied 2 years ago.
Hello, thank you for using this service. I wish to introduce myself. I am Michael, a Research Librarian with 20+ years of experience.

The website offers a overview of the time table needed for a new drug to be approved for the market:

The FDA website offers very exact documentation on how a new drug is approved. The link below has in-depth information on how the process works:

Within the link, there is information under Guidance Documents for NDAs:

Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.
Michael, Librarian
Category: General
Satisfied Customers: 1841
Experience: 20+ years as information professional
Michael and 71 other General Specialists are ready to help you
Customer: replied 2 years ago.

I will be back on this on Sunday or Monday . . . have to go now.



Customer: replied 2 years ago.

Michael--I have done much research, beginning with your citations. I am still looking for information I can't find. One of your cites provided that to accomplish a New Drug Application before the FDA can require many years and a 100,000 page application, all manner of clinical and ohter testing, etc. But that is as to newly developed prescription drug. I am interested in what amounts to a homeopathic, all natural ingredient product which is technically a drug under FDA regs but is a far less complicated analysis. I'd like to believe that the application process is in the months rather than years . . .but I can't find a thing.

Expert:  Michael replied 2 years ago.
I think in this case, it might be best that this question goes to a health expert on our site. I feel that they will have a better understanding and would be happy to assist you.

I will go ahead and send your question over to them and you should hear something soon.

Expert:  Karel1 replied 2 years ago.

I suggest you check out this website and call them. They will give you all the information you need regarding homeopathic products and or medications|9243|fda%20homeopathic||S|b|7299097980&gclid=CJX-_c_LmbkCFYui4Aod-mIAaA

Customer: replied 2 years ago.
Will give rating after checking out info provided.
Expert:  Karel1 replied 2 years ago.
no problem
Customer: replied 2 years ago.
Customer-I have looked into homeopathic remedies through the site you gave me and beyond, and have determined that my proposed product is not homeopathic. However, my product seems to have all natural ingredients, together with Vitamins. It seems to me there should be a faster track for such a product than one containing exotic chemicals, compounds and the like . . . .but I don't really know. Do you have any advice?
Expert:  Karel1 replied 2 years ago.

I think you should call the fda they might be the ones to contact , perhaps they can help you more. You might also try calling vitamin or general nutrition stores and ask them . Unless you can tell me exactly what your product falls under, if its vitamin , or health cream, really the fda is the only place and at least they can guide you.

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