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Drug Information Association Information Technology Initiatives in Drug Registration Submissions January

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>>

Office of New Drug Quality Assessment

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>>

Office of Food Additive Safety

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>>

Office of Food Additive Safety

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>>

Food Safety on the Home Front

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>>

FDA s Role in Responding to Drug Shortages

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>>

Drug Safety Oversight Board Members

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>>

How FDA reviews drug names

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>>

Drug errors involving Keppra and Kaletra

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>>

FDA Prescription Drug Labeling Script

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>>

New Drug Application Submissions

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>>

New Drug Application Submissions 92S 0251

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>>

Center for Drug Evaluation and Research

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>>

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>>


   
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