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Tufts Center for the Study of Drug Development

akimbo 11/4/2008 | 0 (0) | 3 | 0 | 0 | English

Report on the Audit of the Food and Drug Administration's Revolving Fund for Certification and Other Services for Fiscal Year 1994, A-17-94-00040

CMMSdocs 6/30/2008 | 0 (0) | 10 | 0 | 0 | English

*’,,9W[, ** ~ *.. $. .“ 5 : s 5 G “+.,,,,JG & Date From Subject DEPARTMENT OF HEALTH& HUMAN SERVICES Office of Inspector Generai Memorandum , 25 1995 Deputy Inspector General W for Audit Services Report on the Audit of the Food and Drug Administration’s Revolving Fund for Certification and Other Services for Fiscal Year 1994 (A-17-9 ...  more>>

Review of the Food and Drug Administration's Inspection Process of Plasma Fractionators, A-03-97-00350

CMMSdocs 6/30/2008 | 0 (0) | 10 | 0 | 0 | English

2*’ : .* +“’v” %* “ ~ % -0 .. %.,,,,alc & Date DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General From / Subject #AJi!&5%?’-@ 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>>

Institute for Food Development Policy Vol

FDADocs 5/6/2008 | 0 (0) | 13 | 0 | 0 | English

Mar-OS-01 01:56P Food Firs.t/IFDP 510 654 4551 P-01 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>>

Review of the Food and Drug Administration's Processing of a New Drug Application for Therafectin, A-15-94-00023

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>>

Compliance with the Prompt Payment Act by the Food and Drug Administration, A-15-96-40002

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>>

Public Health Service Food and Drug Administration 4 30

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>>

Compliance with the Prompt Payment Act by the Food and Drug Administration, A-15-96-40002

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>>

Review of the Food and Drug Administration's Handling of Issues Related to Conjugated Estrogens, A-15-96-50002

HHS 6/19/2008 | 0 (0) | 7 | 0 | 0 | English

$ ~ 5 “+ �+.,a + % .L 4 *4+ ,* s[w’tct* ~ 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>>

and Spray Drug Products

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>>

Review of the Food and Drug Administration's Processing of 17 Error and Accident Reports Involving Blood, A-03-95-00350

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>>

FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION Table of Contents

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>>

Reporting Process for Blood Establishments to Notify the Food and Drug Administration of Errors and Accidents Affecting Blood, A-03-93-00352

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>>

November The Food Safety People NFPA NATIONAL FOOD

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>>


   
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