Tafenoquine FAERS Individual Case Reports and Narratives from 2019
| Tracking # |
FDA1961462 |
| Submitted | Dec. 23, 2019 |
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Communications
From: Dr. Remington Nevin
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
Individual case reports and narratives for the following three (3) FAERS Case IDs, reported as adverse events for the drug tafenoquine, as listed in the following 2019 FAERS quarterly extracts:
Case ID 16762057, from the 19Q3 FAERS extract
Case ID 16762058, from the 19Q3 FAERS extract
Case ID 15385921, from the 19Q2 FAERS extract
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,
Dr. Remington Nevin
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1961462
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Dr. Remington Nevin Dr. Remington Nevin
Re: Confirmation # FDA1961462
Requester Ctrl #:
In Reply refer to: 2020-119
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Individual case reports and narratives for the following three (3) FAERS Case IDs, reported as adverse events for the drug tafenoquine, as listed in the following 2019 FAERS quarterly extracts: Case ID 16762057, from the 19Q3 FAERS extract Case ID 16762058, from the 19Q3 FAERS extract Case ID 15385921, from the 19Q2 FAERS extract
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.
Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved. Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.
If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at 301-796-8982 or write to us at:
Division of Freedom of Information,
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
Fax: 301-827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
and/or:
Office of the Executive Secretariat
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Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov
Office of Government
Information Services
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E-Mail: ogis@nara.gov
Fax: 202-741-5769 Note: Do NOT reply directly to this E-mail
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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