Post-Marketing Mirena, PTC, Pregnancy, Death
| Tracking # |
2018-9768 |
| Submitted | Nov. 21, 2018 |
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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 - as it pertains to the outcomes of (1) pseudotumor cerebri, (2) pregnancy, and/or (3) death.
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
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. ***
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant 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
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 - as it pertains to the outcomes of (1) pseudotumor cerebri, (2) pregnancy, and/or (3) death
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 - as it pertains to the outcomes of (1) pseudotumor cerebri, (2) pregnancy, and/or (3) death. 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 ...
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.
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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: Food and Drug Administration
This email box is for inquiries to the FDA public liaison. If you have questions about a specific request please contact the person working on your request. That information can be found in your acknowledgement letter.
Regards,
FDA FOIA
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~WRD000
From: Food and Drug Administration
A copy of documents responsive to the request.
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