Request for MIRENA IUS Postmarketing Information
It is a clone of this request.
| Tracking # |
FDA1848633 |
| Submitted | Nov. 9, 2018 |
| Est. Completion | None |
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Communications
From: Claire Tighe
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
A copy of all available information on any postmarketing summaries and/or postmarketing studies of the Mirena IUS levonorgestrel system.
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,
Claire Tighe
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1848633
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
Note: Do NOT reply directly to this E-mail
Claire Tighe Claire Tighe
Re: Confirmation # FDA1848633
Requester Ctrl #:63570
In Reply refer to: 2018-9496
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Postmarketing summaries and/or postmarketing studies of the Mirena IUS levonorgestrel system
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: A copy of all available information on any postmarketing summaries and/or postmarketing studies of the Mirena IUS levonorgestrel system. 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 fulfillin...
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. If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at (301) 796-8982 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov and/or:
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
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Nov. 9, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1848633.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Nov. 9, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1848633.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Nov. 9, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1848633.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
This file was withdrawn by Claire on 11/21/18
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~WRD000