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Documents > food and drug administration
CMMSdocs 6/30/2008 | 0 (0) | 9 | 0 | 0 | English
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FDADocs 5/9/2008 | 0 (0) | 9 | 0 | 0 | English
HHS 6/19/2008 | 0 (0) | 9 | 0 | 0 | English
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DEPARTMENT OF HEALTH& HUMAN SERVICES
Office of Inspector General
Memorandum
MAR -61996
Deputy Inspector General for Audit Services Review of the Food and Drug Administration’s Processes to Review Medical Device Submissions Under the Pre-Market Approval and Investig ... more>>
FDADocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
Members
Amen&n Namst lv&fral Foods Beverly AIawan CrownPoint Ecology Center Beth Knorr Earth Day Coaltiorl Chris Trepal k?/l’h.saveCleveland Medeana Mobar I7eveJandFood Co-op Pat Waina Green Pa@ of Ohio David Ellison Mustard Seed Market & Cafk Phillip Labors
FDA Commissioner 5630 Fishers Lane Room 106 1 (H FA-:305) Rockville, MD 20852 RE: Docket N ... more>>
HHS 6/19/2008 | 0 (0) | 9 | 0 | 0 | English
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FDADocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
December 18,200l
ockets Management Branch Food and Drug Administration EEA-305, Room l-23 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
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Re: Docket 01x)-0361 Comments on Internationals Conference on Harmonisation; Draft guidan Bracketing and Matri ... more>>
HHS 6/19/2008 | 0 (0) | 9 | 0 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICES
L
Office of Inspector General
Washington, D.C. 20201
TO:
Andrew C. von Eschenbach, M.D. Commissioner of Food and Drugs
FROM:
for Audit Services
SUBJECT: Food and Drug Administration's Resolution of Audit Recommendations (A-07-06-03083)
Attached is our final report examining the Food and Drug Adminis ... more>>
FDADocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
Outline for Performing NDA Review
Susan Honig, Division of Oncology Drug Products
Page #
Objectives of the Review
1.0
InitialOrganization
2.0
Summary of Non-clinical disciplines
2.1
Regulatory Review
3.0
Review First Pivotal Trial
4.0
Other Clinical Trials and Non-Clinical Issues
5.0
Summary of Safety and Efficacy
6.0
Oncologic Drugs ... more>>
FDADocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
FDADocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
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’ SEP.20.2001
12:50PM
202
429
4549
NO.719
P.2B
655 15th Street, N.W. Wasfiington, DC 20005-5701 Tel: (202) 452-8444 Fax: 1202) 429+&S19 E-mail: fmibf~rg Web site: www&ni.org s=-
September 20,2001. cd First Class Mail,
Docket Management Branch (EEA-305) Food and Drug Administration 5630 Fisl~ers Lane, ... more>>
FDADocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
e
Public
Wealth
Service
Food and Rockville
Drug Administratian MD 20857
May 17,
2002
Mr. Michael H. Hinckle Kirkpatrick & Lockhart LLP 1800 Massachusetts Ave.,N.W. Second Floor D.C. 20036-1221 Washington,
Dear
Mr.
Hinckle:
Your petition requesting the Food and Drug Administration to permit the filing of an ANDA for a methotrexate sodium ... more>>
xarrnet 10/31/2008 | 0 (0) | 9 | 0 | 0 | English
HHS 6/19/2008 | 0 (0) | 9 | 0 | 0 | English
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“, ‘, % % J*Vd,a ‘L Date From
DEPARTMENT
OF HEALTH
& HUMAN
SERVICES
Office of Inspector General
’
Memorandum
1993
&L or General Headquarters _.
JUN 7
Bryan B. Mitchell Principal Deputy Inspe 9
Sublect
Review of the Food and Drug Administration's Imprest Fund (A-15-92-00019) Audrey F. Manley, M.D., M.P.H. Acting Assi ... more>>
Reps 6/18/2008 | 0 (0) | 9 | 0 | 0 | English
Journal of Exposure Science and Environmental Epidemiology (2008), 1–10 r 2008 Nature Publishing Group All rights reserved 1559-0631/08/$30.00
www.nature.com/jes
US Food and Drug Administration’s Total Diet Study: Dietary intake of perchlorate and iodine
CLARENCE WILLIAM MURRAY, SARA KATHLEEN EGAN, HENRY KIM, NEGA BERU AND PHILIP MICHAEL BOLGER
C ... more>>
HHS 6/19/2008 | 0 (0) | 9 | 0 | 0 | English
Memorandum
From
Richard P. Kusserow Inspector General Audit of Issues Related to the Food and Drug Administration Review of Bovine Somatotropin (A-15-90-00046)
To
James 0. Mason, M.D., Dr. P.H. Assistant Secretary for Health The attached final audit report presents the results of our
audit of the Food and Drug Administration's (FDA) review of
... more>>
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