FDA: All Kratom Investigational New Drug Applications
Tracking # |
2017-3563 |
Submitted | March 20, 2017 |
Est. Completion | None |
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Communications
From: anthony roberts
To Whom It May Concern:
This is a request under the Freedom of Information Act. I hereby request the following records:
I am seeking all Investigational New Drug Applications filed for kratom (Mitragyna speciosa Korth aka ketum) kratom-related (i.e. extracts, concentrates, etc...) drugs, and drugs based on the alkaloids of kratom (specifically mitragynine and 7-hydroxymitragynine). I'd also like the FDA's responses, and all documents included in the application, plus response letters from the FDA, between January 1st, 2007 through the present date (Monday, March 20th, 2017).
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.
Sincerely,
anthony roberts
From: MuckRock.com
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on March 20, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
An acknowledgement letter, stating the request is being processed.
From: Food and Drug Administration
A no responsive documents response.
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