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Documents > food and drug administration
CMMSdocs 6/30/2008 | 0 (0) | 10 | 0 | 0 | English
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DEPARTMENT
OF HEALTH & HUMAN SERVICES
Office of Inspector General
From /
Subject
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Inspector General Michael A. Friedman, M.D. Lead Deputy Commissioner Food and Drug Administration
Memorandum
Review of the Food and Drug Administration’s Inspection Process of Plasma Fractionators ( ... more>>
FDADocs 5/6/2008 | 0 (0) | 13 | 0 | 0 | English
Mar-OS-01
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March 7,ZOOl institute for Food and Development Policy 398 60LhStreet Oakland, CA 94618 Foodfirst@Ifooc@rst,ora US. Food and Drug Administration Dockets Management Branch 5630 Fishers Lane, Room 1061 Rockville, MD 20852 FDADocke&@ox.fda.oov To the U.S. food and Drug Administration: We at t ... more>>
CMMSdocs 6/30/2008 | 0 (0) | 9 | 0 | 0 | English
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CMMSdocs 6/30/2008 | 0 (0) | 21 | 0 | 0 | English
DEPARTMENT
OF HEALTH
& HUMAN
SERVICES
Office
of Inspector
Genera!
Memorandum
Date
AUG
21995
~b Processing of a New Drug Application
From
June Gibbs Brown Inspector Gener
Subject
Review of the P nd Drug Administration’s for Therafectin (A-15-94-OO023)
Philip R. Lee, M.D.
Assistant Secretary for Health
To
The attached final report ... more>>
HHS 6/19/2008 | 0 (0) | 8 | 0 | 0 | English
Dh!?ARTMENT
OF HEALTH
& HUMAN
SERVICES
Office of Inspector General
;L,n,?I ,i iI.r! 5
Date From ’
1997
Memorandum
for Public
Subject
Health
Service
Audits Act by the Food and Drug
Compliance With the Prompt Payment Administration (A-l 5-96-40002)
To
Robert J. Byrd
Associate Commissioner for Management
Food and Drug Administration
... more>>
FDADocs 5/9/2008 | 0 (0) | 18 | 0 | 0 | English
0
Public Health Service ---_____ --.-
Food and Drug Administration Rockville MD 20857
April
30,
2002
Mr. Robert D. Gunderson Phoenix Scientific, Inc. 3915 S. 48th St. Terrace St. Joseph, MO 64503 Dear Mr. Gunderson:
Your petition requesting the Food and Drug Administration to file an ANADA was received by our office on for generic Praziquant ... more>>
CMMSdocs 6/30/2008 | 0 (0) | 10 | 0 | 0 | English
Dh!?ARTMENT
OF HEALTH
& HUMAN
SERVICES
Office of Inspector General
;L,n,?I ,i iI.r! 5
Date From ’
1997
Memorandum
for Public
Subject
Health
Service
Audits Act by the Food and Drug
Compliance With the Prompt Payment Administration (A-l 5-96-40002)
To
Robert J. Byrd
Associate Commissioner for Management
Food and Drug Administration
... more>>
HHS 6/19/2008 | 0 (0) | 7 | 0 | 0 | English
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DEPARTMENT
OF HEALTH&
HUMAN SERVICES
Offtce of
Inspector
General
Memorandum
A&
Date
MAY I 61997
Inspector Gener
FromJune Gibbs Brown
SubjectReview
of the Foo and Drug Administration’s Handling of Issues Related to Conjugated 0“ Estrogens (A-1 5-96-50002) Michael A. Friedman, M.D. Lead Deputy C ... more>>
FDADocs 5/9/2008 | 0 (0) | 50 | 0 | 0 | English
DRAFT-Not for Implementation
Guidance for Industry
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products
CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION
DRAFT GUIDANCE
This document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of p ... more>>
CMMSdocs 6/30/2008 | 0 (0) | 16 | 0 | 0 | English
DEPARTMENT oF HEALTH & HUMAN SERVICES
officed
Inspector General
APR I 2 Igqj
Date From
Memorandum
46
June Gibbs Brown Inspector General
Subject
Review of the F od a d Drug Administration’s Processing of 17 Error and Accident Reports Involvin8 ood (A-03-95-O0350) David A. Kessler, M.D. Commissioner of Food and Drugs
To
The attached final a ... more>>
FDADocs 5/9/2008 | 0 (0) | 71 | 0 | 0 | English
FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Drug Safety and Risk Management Advisory Committee (DSaRM) Holiday Inn Gaithersburg Two Montgomery Village Avenue Gaithersburg, Maryland February 9 & 10, 2006 DRAFT AGENDA DAY ONE
8:00 a.m. Call to Order and Introductions Conflict of Interest Statement Peter Gross, M.D., Ch ... more>>
CMMSdocs 6/30/2008 | 0 (0) | 11 | 0 | 0 | English
DEPARTMENT
OF HEALTH
8s HUMAN
SERVICES
Office of Inspector
General
Date From
MAY 31 19Q5
Memorandum
Sublect
Notify the Food and Drug Administration of Errors and Accidents Affecting Blood (A-03-93-00352) Philip R. Lee, M.D. Assistant Secretary for Health
To
The attached final report provides you with the results of our review of the p ... more>>
FDADocs 5/9/2008 | 0 (0) | 21 | 0 | 0 | English
November 27,2002
The Food Safety People
NFPA
NATIONAL FOOD PROCESSORS ASSOCIATION
Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane km. 1061 Rockville, Maryland 20852 Re: Docket No. OOD-1539 Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Maintenance of Electronic Records
Dear Sir ... more>>
FDADocs 5/9/2008 | 0 (0) | 9 | 0 | 0 | English
akimbo 11/4/2008 | 0 (0) | 3 | 0 | 0 | English
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