Complaints about Trileptal (FDA)

Jeffrey Brown filed this request with the Food and Drug Administration of the United States of America.
Tracking #

FDA1961489

Est. Completion None
Status
Fix Required

Communications

From: Jeffrey Brown


To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

A copy of all complaints submitted to MedWatch, a Consumer Complaint Coordinator or the Office of Prescription Drug Promotion concerning Trileptal (Oxcarbazepine) made between January 1, 2000 and the date this request is processed.

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,

Jeffrey Brown

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1961489
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

Jeffrey Brown Jeffrey Brown
Re: Confirmation # FDA1961489
Requester Ctrl #:
In Reply refer to: 2020-133
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
A copy of all complaints submitted to MedWatch, a Consumer Complaint Coordinator or the Office of Prescription Drug Promotion concerning Trileptal (Oxcarbazepine) made between January 1, 2000 and the date this request is processed.
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
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov
Office of Government
Information Services
National Archives and Administration
8601 Adelphi Road - OGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-Mail: ogis@nara.gov
Fax: 202-741-5769 Note: Do NOT reply directly to this E-mail

From: Food and Drug Administration

Hello,

We have received your FOIA requests. Please give me a call to discuss fees and wait times regarding your requests. My direct contact information is listed below. I contacted the number listed on the request and was told you are not located at that site. Thank you.

Darshini Satchi
Branch Chief FOI Team
Division of Information Disclosure Policy
CDER
301-796-3496

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 sudarshini.satchi@fda.hhs.gov<mailto:sudarshini.satchi@fda.hhs.gov>.

From: Food and Drug Administration

Hello,

I'm following up to my earlier e-mail. Thanks.

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