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Summary of Food and Drug Administration s Presentation

CMMSdocs 6/30/2008 | 0 (0) | 13 | 0 | 0 | English

Food and Drug Administration The following is a summary of FDA’s presentation on 12/5/2002. Potential FDA Set-Asides: 1. Document Control Room Services for CDER 2. Dissemination of Information on Contaminated Food 3. Framework for Qualified Health Claims 4. Retroviral Support Panels 5. Cafeteria Services at the Muirkirk Complex 6. Graphics Services ...  more>>

State Food and Drug Administration SFDA August

NTIA 6/30/2008 | 0 (0) | 69 | 1 | 0 | English

US-China Joint Commission on Commerce and Trade Medical Device and Pharmaceutical Subgroup Pharmaceutical Task Force Meeting August 30, 2005 Beijing, China Overview The Pharmaceutical Task Force under the U.S. – China Joint Commission on Commerce and Trade (JCCT) Medical Devices and Pharmaceuticals Subgroup met in Beijing, China on August 30, 2005. ...  more>>

Audit of Issues Related to the Food and Drug Administration Review of Bovine Somatotropin, A-15-90-00045

HHS 6/19/2008 | 0 (0) | 14 | 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>>

Review of Allegations of Mismanagement at the Food and Drug Administration - Newark District Office, A-02-91-02522

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

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General AUG Date From Bryan B. Mitchell Principal Deputy Review of Allegations of Mismanagement at the Food and Drug Newark District Office (A-02-91-02522) Administration To James 0. Mason, M.D., Dr. P.H. Assistant Secretary for Health The attached final audit report provides you wit ...  more>>

Follow-up Review of the Food and Drug Administration's Generic Drug Management Information System, A-15-91-00026

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

. w I . - .d DEPARTMENT OF HEALTH 8a HUMAN SERVICES Dffice Iof General Date FIOITI . OCT 26 1992 Bryan B. Mitchell Principal Deputy Follow-up Review of the Food and Drug Administration's Generic Drug Management Information System (A-15-91-00026) James 0. Mason, M.D., Dr. P.H. Assistant Secretary for Health The attached final ...  more>>

Follow-Up Review of the Food and Drug Administration's Generic Drug Approval Process, A-15-91-00025

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

DEPARTMENT OF HEALTH HUMAN of Inspector General From B. Mitchell Principal Deputy Follow-Up Review of the Food and Drug Administration's Generic Drug Approval Process (A-15-91-00025) James 0. Mason, M.D., Dr. P.H. Assistant Secretary for Health The attached final report presents the results of our up review of the Food and Drug Administration' ...  more>>

Follow-Up Review On Internal Control Weaknesses in the Food and Drug Administration's Medical Device 510 (k) Review Process, A-03-92-00605

HHS 6/19/2008 | 0 (0) | 12 | 0 | 0 | English

DEPARTMENT HEALTH HUMAN Off of Inspector General Date . Memorandum w From * &Li Bryan B. Mitchell Principal Deputy Inspect r General 5 Follow-Up Review On Internal Control Weaknesses in the Food and Drug Administration's Medical Device 510(k) Review Process (A-03-92-00605) Audrey F. Manley Acting Assistant Secretary for Health The  ...  more>>

Financial Audit of the Food and Drug Administration's Revolving Fund for Certification and Other Services, A-15-93-00007

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

DEPARTMENT OF HEALTH 8a HUMAN SERVICES Office of inspector General Memorandum Date From Subject Bryan B. Mitchell &ad Principal Deputy Inspector General 7 Financial Audit of the Food and Drug Administration’s Revolving Fund for Certification and Other Services (A-15-93-7) Philip R. Lee, M.D. Assistant Secretary for Health , To The att ...  more>>

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

HHS 6/19/2008 | 0 (0) | 10 | 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>>

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

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

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) | 10 | 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>>

Review of the Food and Drug Administration's Processes to Review Medical Device Submissions Under the Pre-Market Approval and Investigational Device Exemption Programs, A-15-95-50001

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

~styl, +’ *.. 11 ‘r � .“ t : , % ‘+ ‘+,,,,,0 4(L Date From Subject To 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>>

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

HHS 6/19/2008 | 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 Processing of 17 Error and Accident Reports Involving Blood, A-03-95-00350

HHS 6/19/2008 | 0 (0) | 13 | 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>>


   
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