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Documents > food and drug administration
FDADocs 5/5/2008 | 0 (0) | 19 | 0 | 0 | English
February 11, 2003 VIA EMAIL (www.fda.gov/dockets/ecomments) Dockets Management Branch HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket No. 02D-0324. Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals 67 Federal Register 57828, S ... more>>
FDADocs 5/5/2008 | 0 (0) | 8 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 22 | 3 | 0 | English
GovernmentDocs 5/4/2008 | 0 (0) | 40 | 1 | 0 | English
COMPLIANCE POLICY GUIDE 160.900
Prescription Drug Marketing Act – Pedigree Requirements under 21 CFR Part 203 December 2006
Purpose
This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR P ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 53 | 1 | 0 | English
Safety Page
Stemming drug errors from abbreviations
Problem: Abbreviations and tions that have been incorrectly ation for the investigational drug CPX, being tested in cystic fibrosis, acronyms save time; they can interpreted. Abbreviations and acronyms are sounds similar to CTX, which is also lead to medication errors. Not all practitioners inter ... more>>
FDADocs 5/9/2008 | 0 (0) | 33 | 0 | 0 | English
FDADocs 5/5/2008 | 0 (0) | 33 | 0 | 0 | English
M E M O R A N D UM
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
Center for Food Safety and Applied Nutrition
DATE: FROM: Alan M. Rulis, Director Office of Food Additive Safety CFSAN, HFS-200 SUBJECT: Docket 92S-0251 - Notification TO: Chief, Dockets Management Branch, HFA-305 Pursuant to 21 CFR Part 1 ... more>>
FDADocs 5/9/2008 | 0 (0) | 40 | 0 | 0 | English
M E M O R A N D UM
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
Center for Food Safety and Applied Nutrition
DATE: FROM: Alan M. Rulis, Director Office of Food Additive Safety CFSAN, HFS-200 SUBJECT: Docket 92S-0251 - Notification TO: Chief, Dockets Management Branch, HFA-305 Pursuant to 21 CFR Part 1 ... more>>
FDADocs 5/9/2008 | 0 (0) | 30 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 20 | 0 | 0 | English
FDADocs 5/5/2008 | 0 (0) | 22 | 0 | 0 | English
CENTER FOR DRUG EVALUATION AND RESEARCH
Office of Medical Policy (HFD-040) Robert Temple, MD 301-594-6758 Deputy Director Rachel Behrman, MD, M.P.H.
Associate Director for Medical Informatics Randy Levin Associate Director for Policy Jane Axelrad Controlled Substance Staff Deborah Leiderman, MD Drug Safety Oversight Board Susan Cummins, MD., M.P.H. ... more>>
FDADocs 5/5/2008 | 0 (0) | 8 | 0 | 0 | English
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FDADocs 5/9/2008 | 0 (0) | 51 | 0 | 0 | English
FDADocs 5/5/2008 | 0 (0) | 6 | 0 | 0 | English
UNITED STATES OF AMERICA BEFORE THE FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
In the Matter of: Enrofloxacin for Poultry: Withdrawal of Approval of New Animal Drug Application NADA 140-828 FDA DOCKET: OON-1571 Date: March 19,2003
ORDER On March 17, 2003 the Center for Veterinary Medicine (CVM) requested the opportunity ... more>>
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