Potential Scheduling of Gabapentin

Curtis Waltman filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2016-9080
Status
Completed

Communications

From: Curtis Waltman

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

Any FDA documents, including but not limited to internal communications, internal and external emails, reports, and opinions, on Gabapentin (aka Neurontin ). I am especially interested in the process (and data used) by which the FDA has determined that it should not be a scheduled drug, and the internal communication which has helped arrive at this decision.

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,

Curtis Waltman

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Simpson, Cheree

Hello:

I am trying to contact Curtis Waltman, regarding his Food and Drug Administration Freedom of Information request dated October 27, 2016. Please give me a call at 301-796-3458 to discuss your request.

Best Regards,

Cheree

Cheree N. Simpson, JD
Lead Consumer Safety Officer
Food and Drug Administration
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
(301)796-3458 Direct Line

This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

From: Curtis Waltman

Hi Cheree,
Just wondering about what the delay is, and if there was any more clarification you needed that I could give you. Thank you!
Best,
Curtis Waltman
MuckRock News

From: Simpson, Cheree

Thank you for your response. We sent the information to Mr. Waltman on January 12, 2017. Please let me know if you need any additional information.

Regards,
Cheree

This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

From: Curtis Waltman

Hello,
These records were never received in this office, could you please re-send? Thank you.

From: Curtis Waltman

Hi Cheree,

Our office never received these records. Could you please resend?

Thank you,
Curtis Waltman
MuckRock News

From: Simpson, Cheree

Hi Curtis,

Please provide me a phone number where I can reach you.

Thanks,
Cheree

This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov%3cmailto:cheree.simpson@fda.hhs.gov>

From: Curtis Waltman

Hi Cheree,
You can reach me at the office at 617-307-6359. Thank you!

Sincerely,
Curtis Waltman

From: Food and Drug Administration

A copy of documents responsive to the request.

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