Vasalgel - FDA materials

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

2017-8564

Est. Completion None
Status
No Responsive Documents

Communications

From: Beryl Lipton

To Whom It May Concern:

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

Any and all files and materials related to or regarding any and all products called Vasalgel or submitted by the Parsemus Foundation.

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,

Beryl Lipton

From: Kotler, Sarah

Dear Requester,

FDA has received your request regarding Vasagel. Can you please provide some additional information regarding this product, specifically whether it is a human drug? This will allow us to properly assign your request, and we are unable to find this information. Once we have this additional information, we can log your request.

Thank you,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@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: MuckRock

Hello Ms. Kotler,

Vasalgel is a human drug, which I believe is currently in the clinical trial stage. More information on it can be found here: https://www.parsemus.org/projects/vasalgel/.

Thank you for your time.

Best wishes,
Beryl

From: Kotler, Sarah

Hi, thanks for your email. Now that we have this information, we can log and assign your request to the Center for Drugs. If there are other requests you believe have not been acknowledged, let me know (per your voicemail). I'll be available tomorrow morning in my office from 8 AM until about 10 AM, and then in and out of meetings until about 4 PM.

Thanks,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@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: Food and Drug Administration

An interim response, stating the request is being processed.

From: Food and Drug Administration

Good afternoon. I am copying the FOIA Office for the Center for Devices, which is processing your request. That office will provide you with a status.

Thanks,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@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: Food and Drug Administration

Hello Beryl Lipton,

I received your status request. I have sent your request to one of the component offices to see if they have any information. I will keep you updated once I hear back from them.

Thanks,

Jeffrey Hahn
Government Information Specialist
Centers for Devices & Radiological Health (CDRH)
Office of Communication and Education
U.S. Food and Drug Administration
Tel: 301-796-5282
jeffrey.hahn@fda.hs.gov<mailto:jeffrey.hahn@fda.hs.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/>
Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:

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From: Beryl Lipton

Hello Mr. Hahn,

Thanks so much for the update. If there's anything I can do, please feel free to call me at 617-299-1832.

I hope you have a lovely weekend.

Best wishes,
Beryl

From: Food and Drug Administration

Hello Beryl Lipton,

Your request came back with no records. I have submitted this to my boss and you will be receiving a letter in the mail.

Thanks,

Jeffrey Hahn
Government Information Specialist
Centers for Devices & Radiological Health (CDRH)
Office of Communication and Education
U.S. Food and Drug Administration
Tel: 301-796-5282
jeffrey.hahn@fda.hs.gov<mailto:jeffrey.hahn@fda.hs.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/>
Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:

https://www.research.net/s/cdrhcustomerservice?O=800&D=860&B=863&E=&S=E

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