Documents > food and drug administration


Food and Drug Administration's Resolution of Audit Recommendations, A-07-06-03086

HHS 6/19/2008 | 0 (0) | 3 | 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>>

Food and Drug Administration's Resolution of Audit Recommendations, A-07-06-03086

CMMSdocs 6/30/2008 | 0 (0) | 11 | 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>>

Food and Drug Administration's Resolution of Audit Recommendations, A-07-06-03086

CMMSdocs 6/30/2008 | 0 (0) | 11 | 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>>

Review of the Food and Drug Administration's Citizen Petition Process, A-15-97-50002

HHS 6/19/2008 | 0 (0) | 11 | 0 | 0 | English

DEPARTME NT HEALTH HUMAN SERVICES off ice of Inspector General I7 Date From Memorandum Subject June Gibbs Brow 236 Inspector Gener -e Review of the Food and Drug Administration’s Citizen Petition Process (CIN: A-15-97-50002) Michael A. Friedman, M.D. Lead Deputy Commissioner Food and Drug Administration The attached final report provides you ...  more>>

Joint Food Safety and Inspection Service and Food and Drug Administration Meeting

RMA 6/18/2008 | 0 (0) | 48 | 0 | 0 | English

Food and Drug Administration AGENDA Joint Food Safety and Inspection Service and Food and Drug Administration Meeting Regulatory Approach Relating To Jurisdiction Over Certain Food Products That Contain Meat and Poultry December 15, 2005 Donald E. Stevens Convention Center Second Floor, South Ballroom, Room #40 Rosemont, Illinois 8:30–10:00 a.m. Re ...  more>>

End Points and United States Food and Drug Administration Approval of Oncology Drugs Cancer Drug Approval Endpoints

FDADocs 5/9/2008 | 0 (0) | 32 | 1 | 0 | English

End Points and United States Food and Drug Administration Approval of Oncology Drugs By John R. Johnson, Grant Williams, and Richard Pazdur Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing ...  more>>

Review of the Food and Drug Administration's Headquarters Imprest Fund, A-15-92-00019

HHS 6/19/2008 | 0 (0) | 9 | 0 | 0 | English

\ +* , d*\rw,.y . 4 4 “, ‘, % % 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>>

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>>

Review of the Food and Drug Administration's Handling of Adverse Drug Reaction Reports, A-15-98-50001

HHS 6/19/2008 | 0 (0) | 22 | 0 | 0 | English

DEPARTMENT DEC I OF HEALTH & HUMAN SERVICES Office of inspector General 4 1999 Memorandum Date From JuneGibbs Brown Review of the Food and Drug Administration’s Handling of Adverse Drug Reaction Reports (CIN: A-15-98-50001) JaneE. Henney, M.D. Commissioner of Food and Drugs The attachedfinal report presentsthe results of the Office of Ins ...  more>>

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

HHS 6/19/2008 | 0 (0) | 17 | 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>>

Public Health Service Food and Drug

FDADocs 5/5/2008 | 0 (0) | 28 | 0 | 0 | English

i”*\ Cl,,.., Public Health Service Food and Drug Administration Rockville MD 20857 . July 2, 2001 Deborah L. Theres Ferndale Laboratories 780 West Eight Mile Ferndale, MI 48220 Inc. Road Dear MS,. Theres: Your petition requesting the Food 'and Drug Administration to make a determination that an abbreviated new drug applicationn (ANDA) is  ...  more>>

Drug Administration Metabolism

sammyc2007 4/22/2008 | 0 (0) | 55 | 4 | 0 | English

   
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