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Michael
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Category: General
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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: 1 year ago.
Category: General
Expert:  Michael replied 1 year 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 drugs.com offers a overview of the time table needed for a new drug to be approved for the market:

http://www.drugs.com/fda-approval-process.html

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:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/

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: 1323
Experience: 20+ years as information professional
Michael and 126 other General Specialists are ready to help you
Customer: replied 1 year ago.

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


 


thanks.

Customer: replied 1 year 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 1 year 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.

Michael
Expert:  Karel1 replied 1 year 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

 

http://www.registrarcorp.com/fda-drugs/homeopathic/registration.jsp?lang=en&s_kwcid=TC|9243|fda%20homeopathic||S|b|7299097980&gclid=CJX-_c_LmbkCFYui4Aod-mIAaA

Customer: replied 1 year ago.
Will give rating after checking out info provided.
Expert:  Karel1 replied 1 year ago.
no problem
Customer: replied 1 year 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 1 year 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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Michael
Michael
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20+ years as information professional