FDA: Adverse Event Reports on Selective Androgen Receptor Modulators

Anthony Roberts filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking # 2017-6368
Status
Completed

Communications

From: Anthony Roberts

To Whom It May Concern:

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

I am seeking all Adverse Event Reports involving Selective Androgen Receptor Modulators filed between January 1st, 2008 and October 31st, 2017.

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,

anthony roberts

From: Food and Drug Administration

An interim response, stating the request is being processed.

From: Food and Drug Administration

Dear Mr. Roberts,

This is in response to your November 3, 2017 Freedom of Information Act (FOIA) request to the Center for Food
Safety and Applied Nutrition (CFSAN) seeking copies of records related to:

* ANDROGEN RECEPTOR MODULATORS - CAERS 1/1/08 TO 10/31/17

This information is publicly available at the link below which contains information regarding the CFSAN Adverse Event Reporting System (CAERS) online database that can be downloaded and searched, at your convenience. The database is available in ASCII format and can be saved as an Excel spreadsheet for formatting and searching once downloaded. The Adverse Event Reporting System data file contains data reported by consumers, health care practitioners and mandatory reports by industry with a date range starting January 2004 through June 2017. Please note the latter date is the most recent available.

http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm

Your request is granted in full. CFSAN considers your request closed.

If you are not satisfied with any aspect of the processing and handling of this request, please contact
Samantha.Wilde@fda.hhs.gov or call 240-402-0003. You also have the right to contact:

FDA FOIA Public Liaison
Office of the Executive Secretariat
US Food & Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>

Please do not submit payment until you receive an invoice. The following charges for this request to date may be included in a monthly invoice:

Reproduction=$0.00 Search=$0.00 Review $0.00 Other $0.00 Total=$0.00

Sincerely,

Kimberly Jones
Administrative Support Specialist (CNI Technical Services Contractor)
Freedom of Information Act (FOIA)
Center for Food Safety & Applied Nutrition (CFSAN)
Office of Regulations, Policy & Social Sciences (ORPSS)
PH (240) 402-1825
Kimberly.jones@fda.hh.gov

[cid:image001.png@01D29CBA.FA769050]<http://www.fda.gov/>

[cid:image002.jpg@01D29CBA.FA769050]<https://www.facebook.com/FDA> [cid:image003.jpg@01D29CBA.FA769050] <https://twitter.com/US_FDA> [cid:image004.jpg@01D29CBA.FA769050] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D29CBA.FA769050] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D29CBA.FA769050] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Food and Drug Administration

Dear Mr. Roberts,

Your request was answered and a link to the public database containing the information you are seeking was provided, no further action is required and CFSAN considers your request closed.

Thank you
Samantha

Samantha Wilde
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations, Policy and Social Sciences (ORPSS)
U.S. Food and Drug Administration (FDA)
Tel: 240-402-0003
samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Anthony Roberts

Hi,

Thanks so much for your help with this request! I really appreciate it.

Sincerely,
Anthony Roberts

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