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Documents > food and drug administration
FDADocs 5/5/2008 | 0 (0) | 11 | 0 | 0 | English
I
In Cooperation
With:
Overview
The U.S. Food and Drug Administrationhas undertaken manyInforma-
The U.S. Food andDrug Administration and PhRMA
Program
Chairpersons:
Krishan K. Arora, PhD, International irector, D ElectronicSubmissions, rug RegulatoryAffairs D Novartis Pharmaceuticals Corporation David C. Isom, Acting Director, Office of Inf ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 9 | 0 | 0 | English
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF PHARMACEUTICAL SCIENCE OFFICE OF NEW DRUG QUALITY ASSESSMENT
Main Tel: 301-796-1900 Fax: 301-796-9748
OFFICE OF THE DIRECTOR
DIRECTOR Moheb M. Nasr, Ph.D.
(DBNSC)
Room 2630, WO21 Bldg, Mail Code: HFD10903 New Hampshire Avenue Sil ... more>>
FDADocs 5/9/2008 | 0 (0) | 56 | 2 | 0 | English
GovernmentDocs 5/5/2008 | 0 (0) | 37 | 0 | 0 | English
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION OFFICE OF OPERATIONS OFFICE OF FOOD ADDITIVE SAFETY
OFFICE OF THE DIRECTOR
DIRECTOR Laura M. Tarantino, Ph.D. DEPUTY DIRECTOR George H. Pauli, Ph.D.
(DBFBC)
DIVISION OF PETITION REVIEW
DIVISION OF CHEMISTRY RESEARCH AND ENVIRONMENTAL ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 51 | 0 | 0 | English
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION OFFICE OF OPERATIONS OFFICE OF FOOD ADDITIVE SAFETY
OFFICE OF THE DIRECTOR
DIRECTOR Laura M. Tarantino, Ph.D. DEPUTY DIRECTOR George H. Pauli, Ph.D.
(DBFBC)
DIVISION OF PETITION REVIEW
DIVISION OF CHEMISTRY RESEARCH AND ENVIRONMENTAL ... more>>
FDADocs 5/8/2008 | 0 (0) | 37 | 0 | 0 | English
Food Safety On The Home Front
What comes to mind when you think of a clean kitchen? Shiny waxed floors? Spotless counters and neatly arranged cupboards? These things are important, but a truly “clean” kitchen—that is, one that ensures safe food—relies on more than just looks: It also depends on safe food practices.
Some safe food basics are:
• Was ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 47 | 0 | 0 | English
SPECIAL FEATURE
Drug shortages Transitions
S P E C I A L F E AT U R E
FDA’s role in responding to drug shortages
VALERIE JENSEN, LORENE M. KIMZEY, AND MARK J. GOLDBERGER
Am J Health Syst Pharm. 2002; 59:1423-5
T
he Drug Shortage Program at the Food and Drug Administration (FDA) is a division of the Center for Drug Evaluation and Research (CDER ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 17 | 0 | 0 | English
Roster current as of April 16, 2008
Drug Safety Oversight Board Roster
Chair (Non-voting) • Paul Seligman, M.D.,M.P.H. Associate Director for Safety Policy and Communication Center for Drug Evaluation and Research Executive Secretary (Non-voting) • Steven Osborne, M.D. Executive Director, Drug Safety Oversight Board Safety Policy and Communication ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 54 | 2 | 0 | English
Safety Page
How FDA reviews drug names
Editors’ note: According to a 1999 Institute of Medicine report, approximately 7,000 deaths occur yearly due to medication errors. To help save lives, the Food & Drug Administration has agreed to share information on its drug error prevention activities with Drug Topics through this new quarterly column. What ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 15 | 0 | 0 | English
Safety Page
Drug errors involving Keppra and Kaletra
T
he Food & Drug Administration would like to alert healthcare providers that dispensing errors between Keppra (levetiracetam) and Kaletra (lopinavir/ritonavir) have occurred. The FDA has received four reports of confusion between Keppra and Kaletra, one of which resulted in administraIntended ... more>>
FDADocs 5/9/2008 | 0 (0) | 73 | 1 | 0 | English
Script - An Introduction to the Improved FDA Prescription Drug Labeling
Welcome and thank you for participating in the Food and Drug Administration, Center for Drug Evaluation and Research continuing education activity on the improved prescription drug labeling. This activity is designed to give you a better understanding of: • • • the revised pre ... more>>
FDADocs 5/5/2008 | 0 (0) | 17 | 0 | 0 | English
MEMORANDUM
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research
DATE:
January 29, 1999
FROM:
David Isom, Directo Office of Information Technology CDER, HFD-070
SUBJECT:
Docket 925-0251- Update Transmittal
TO:
Chief, Dockets Management Branch, HFA-305
Pursuant to ... more>>
FDADocs 5/9/2008 | 0 (0) | 22 | 0 | 0 | English
MEMORANDUM
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research
DATE:
January 29, 1999
FROM:
David Isom, Directo Office of Information Technology CDER, HFD-070
SUBJECT:
Docket 925-0251- Update Transmittal
TO:
Chief, Dockets Management Branch, HFA-305
Pursuant to ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 11 | 0 | 0 | English
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF THE CENTER DIRECTOR
DIRECTOR Steven K. Galson, M.D., M.Ph.
(DBN)
Main Tel: 301-594-5400 Fax: 301-594-6197 Room 7100, RKWL2 Bldg, Mail Code: HFD-001 Rockville, MD 20852
OFFICE OF REGULATORY POLICY DIRECTOR Jane A. Axelrad (DBNAA)
... more>>
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>>
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