Studies into effectiveness, safety of naloxone

Todd Feathers filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2014-3011
Status
Completed

Communications

From: Todd Feathers

To Whom It May Concern:

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

All studies since 2012 into the safety and effectiveness of naloxone as a treatment for overdoses.

I also request that all fees be waived as I am a journalist -- employed by MuckRock and the Boston Globe -- and intend to use any pertinent information I receive as a result of this request to educate the public.

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,

Todd Feathers

From: Lee, Elizabeth J. (FDA)

Hi Mr. Feathers,

Our office has two tracks for FOI requests: simple and complex. The estimated wait time for simple track requests is 20 business days. The estimated wait time for complex track requests is 18 - 24 months. You did not specify which Naloxone applications you are seeking information for. On the simple track, we can provide you with readily available approval information (will include safety and effectiveness information) on all Naloxone applications since 2012.

If you are interested in taking information that we have readily available, we can simple track your request and begin processing your request immediately. Please let me know if you would like to simple track your request or wait 18 - 24 months in the complex track.
Thanks,

Elizabeth Lee
Lead Regulatory Counsel
FDA/CDER/ORP/Division of Information Disclosure Policy
301-796-3456 (direct)/301-796-3603 (main)/301-431-6351 (fax)
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 elizabeth.lee@fda.hhs.gov.
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From: Todd Feathers

Ms. Lee,

Thank you for your response. I would like to receive documents readily available through the simple track.

Todd Feathers

From: Lee, Elizabeth J. (FDA)

Thank you for your reply, Mr. Feathers.

Elizabeth Lee
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 elizabeth.lee@fda.hhs.gov.

From: Food and Drug Administration

A copy of documents responsive to the request.

From: Food and Drug Administration

A cover letter granting the request and outlining any exempted materials, if any.

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