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Office of New Animal Drug Evaluation

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE OFFICE OF NEW ANIMAL DRUG EVALUATION OFFICE OF THE DIRECTOR DIRECTOR Steven D. Vaughn, D.V.M. DEPUTY DIRECTOR FOR ADMINISTRATION David R. Newkirk, Ph.D. DEPUTY DIRECTOR FOR POLICY Vacant (DBVC) Main Tel: 240-276-8300 Fax: 240-276-8242 Room 386 Bldg M ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of Food Additive Safety

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>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of Food Additive Safety

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

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Center for Food Safety and Applied Nutrition

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION OFFICE OF THE CENTER DIRECTOR OFFICE OF MANAGEMENT SYSTEMS DIRECTOR Denise K. Riley DIRECTOR Robert E. Brackett, Ph.D. (DBFAC) OFFICE OF SCIENCE DIRECTOR Robert L. Buchanan, Ph.D. OFFICE OF REGULATIONS AND POLICY DIRECTOR Leslye Fras ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of New Drug Quality Assessment

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>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of Oncology Drug Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF NEW DRUGS OFFICE OF ONCOLOGY DRUG PRODUCTS Main Tel: 301-796-2340 Fax: 301-796-9909 Room 2212, WO22 Bldg, Mail Code: HFD10903 New Hampshire Avenue Silver Spring, MD 20993 OFFICE OF THE DIRECTOR DIRECTOR Richard Pazdur, M.D. (DBNRM ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of Drug Evaluation III

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF NEW DRUGS OFFICE OF DRUG EVALUATION III OFFICE OF THE DIRECTOR DIRECTOR Julie G. Beitz, M.D. (DBNRC) Main Tel: 301-796-2100 Fax: 301-796-9906 Room 5214, WO22 Bldg, Mail Code: HFD10903 New Hampshire Avenue Silver Spring, MD 20993 ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of Drug Evaluation II

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF NEW DRUGS OFFICE OF DRUG EVALUATION II Main Tel: 301-796-2310 Fax: 301-796-9717 Room 3214, WO22 Bldg, Mail Code: HFD10903 New Hampshire Avenue Silver Spring, MD 20993 OFFICE OF THE DIRECTOR DIRECTOR Robert J. Meyer, M.D. (DBNRB) ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Office of Drug Evaluation I

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF NEW DRUGS OFFICE OF DRUG EVALUATION I Main Tel: 301-796-2270 Fax: 301-796-9840 Room 4212, WO22 Bldg, Mail Code: HFD10903 New Hampshire Avenue Silver Spring, MD 20993 OFFICE OF THE DIRECTOR DIRECTOR Robert J. Temple, M.D. (Acting) ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Center for Drug Evaluation and Research

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>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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OFFICE OF EXTERNAL RELATIONS ASSISTANT COMMISSIONER Thersea A. Toigo (Acting)(DABA) OFFICE OF EXECUTIVE SECRETARIAT DIRECTOR LaJuana Caldwell OFFICE OF LEGISLATION ASSISTANT COMMISSIONER Stephen Mason (Acting) (DABC) OFFICE OF PUBLIC AFFAIRS ASSISTANT COMMISSIONER (DABD) Julie Zawisza DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTR ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Guidance for Industry Reports on the Status of Postmarketing Study Commitments Implementation of Section of the Food and Drug Administration Modernization Act of

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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FOOD AND DRUG ADMINISTRATION Center For Biologics Evaluation

FOOD AND DRUG ADMINISTRATION Center For Biologics Evaluation and Research Memorandum DATE: October 11, 2000 FROM: Douglas Frazier, Review Committee Chairperson, HFM-345, CBER/DH TO: Sheila Buck, Regulatory Reviewer, HFM-380, CBER/DBA SUBJECT: Biologics License Application STN BL 103788/0 Summary Basis for Approval The following is a summary basi ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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OTC Cough Cold Drug Products

OTC Cough/Cold Drug Products 21 C.F.R. Part 341 The following table summarizes the individual cough/cold ingredients, including dosage levels, that are generally recognized as safe and effective for use in OTC cough/cold preparations when formulated and labeled in compliance with the final regulations at 21 C.F.R. Part 341. Cough/cold preparations ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

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Prescription Drug Marketing Act December

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>>

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categories:legal > Government >


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Documents > food and drug administration

Office of New Animal Drug Evaluation

Office of Food Additive Safety

Office of Food Additive Safety

Center for Food Safety and Applied Nutrition

Office of New Drug Quality Assessment

Office of Oncology Drug Products

Office of Drug Evaluation III

Office of Drug Evaluation II

Office of Drug Evaluation I

Center for Drug Evaluation and Research

Food and Drug Administration

Guidance for Industry Reports on the Status of Postmarketing Study Commitments Implementation of Section of the Food and Drug Administration Modernization Act of

FOOD AND DRUG ADMINISTRATION Center For Biologics Evaluation

OTC Cough Cold Drug Products

Prescription Drug Marketing Act December