Requests for withdrawal of drug approval

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

2014-2841
Submitted April 1, 2014
Status
Completed

Communications

From: Todd Feathers

Subject: None

Fax

To Whom It May Concern:

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

All letters or other forms of communication since Jan. 1, 2013 from companies requesting the withdrawal of approval of a New Drug Applications (NDA).

I also request that all fees be waived as I am a member of the news media -- employed by MuckRock and the Boston Globe -- and intend to use any pertinent information I receive as a result of this request to educate the public.

In the event that fees cannot be waived, 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,

Todd Feathers

From: Food and Drug Administration

Subject: None

Mail (Postmarked April 8, 2014)

A letter stating the request for reduced or waived fees has been accepted.

From: Hyder, John

Subject: None

Email

Good Morning Mr. Feathers,

My name is Matt Hyder and I am with the Food and Drug Administration Center for Biologics Evaluation and Research’s (CBER) Freedom of Information staff. I am e-mailing you in regards to your Freedom of Information Act (FOIA) Request # 2014-2841. Please find below CBER’s partial response and responsive documents to your request.


CBER’s Partial Response:

CBER’s Responsive Records:


Respectfully,
Matt Hyder
Consumer Safety Officer
CBER - ALFOI Branch
FDA
10903 New Hampshire Avenue
Building 71
Silver Spring, MD 20993-0002
Phone: 240-402-8079

From: Hyder, John

Subject: None

Email

Good Evening Mr. Feathers,

I am e-mailing you in regards to your Freedom of Information Act (FOIA) Request # 2014-2841. Please find below CBER’s response and responsive documents to your request.


CBER’s Response:

CBER’s Responsive Records:
Respectfully,
Matt Hyder
Consumer Safety Officer
CBER - ALFOI Branch
FDA
10903 New Hampshire Avenue
Building 71
Silver Spring, MD 20993-0002
Phone: 240-402-8079

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