FDA: All Kratom Investigational New Drug Applications

anthony roberts filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking # 2017-3563
Est. Completion None
Status
No Responsive Documents

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: 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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