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Guidance for Industry Day Generic Drug Exclusivity Under the Hatch Waxman Amendments to the Federal Food Drug and Cosmetic Act

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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How FDA reviews drug names

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>>

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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Stemming drug errors from abbreviations

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>>

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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Drug errors involving Keppra and Kaletra

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>>

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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FDA s Role in Responding to Drug Shortages

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>>

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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Drug Safety Oversight Board Members

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>>

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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Irradiation of Food An FDA Perspective

Food Reviews International, 2(1), 79-107(1986) IRRADIATION O FOODS- F AN FDA PERSPECTIVE GEORGE H. PAULI and CLYDE A. TAKEGUCHI Food and Dmg Administration Center for Food Safety and Applied Nutrition Division of Food and Color Additives Washington, D.C. Abstract Food irradiation has been a subject of controversy since its first use as a food ... 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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Food Advisory Committee Food Biotechnology Subcommittee Meeting September

Federal Register / Vol. 68, No. 172 / Friday, September 5, 2003 / Notices heading of this document. You should annotate and organize your comments to identify the specific questions to which they refer. To ensure timely handling, the outer envelope should be clearly marked with the docket number listed in the heading of this document along with the ... 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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Pet Food Recalls List

Pet Bird Bird Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Cat Manufacturer United Pet Group Inc. United Pet Group Inc. American Nutrition American Nutrition American Nutrition American Nutr ... 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

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Sterile Drug Process Inspections

EDIT: Made available by ORA/OE/DCIQA 01/29/03 - undated MS Word file received from CDER ; table format Added & spelling corrections made. PROGRAM CHAPTER 56 - DRUG QUALITY ASSURANCE 7356.OO2A SUBJECT: IMPLEMENTATION DATE STERILE DRUG PROCESS INSPECTIONS *Upon Receipt* COMPLETION DATE 9/30/93 DATA REPORTING PRODUCT CODES PRODUCT/ASSIGNMENT CO ... 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 and FDA Staff Intravascular Administration

Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: April 15, 2005 This guidance supersedes “Guidance for Industry and FDA Reviewers on the Guidance on Premarket Notifications for Intravascular Administration Sets,” issued October 12, 2000. For questions regarding thi ... 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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Public Health Service Food and Drug Adminstration

Public Health Service - Food and Drug Adm~n~stration 8 7 5 7 Georgia Avenue Silver Spring MD 2091 0 TO: ALL MANUFACTURERS, IMPORTERS AND POTESJTIAL MANUFACTURERS O S N A P PRODUCTS. F ULM ULM SUBJECT: POLICY ON WARNING LABEL REQUIRED ON S N A P PRODUCTS. BACKGROUND: The Center f o r Devices and Radiological Health has f o b d numerous inported ... 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

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Guidance for Industry Implementation of Section of the Food and Drug Administration Modernization Act of Elimination of Certain Labeling Requirements

Guidance for Industry Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 — Elimination of Certain Labeling Requirements Additional copies are available from: the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 Inter ... 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 Advisory Committees Implementing Section of the Food and Drug Administration Modernization Act

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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Medical Device Provisions Of the Food And Drug Administration Amendments Act Of Preliminary PDF

INDEX TO THE MEDICAL DEVICE PROVISIONS OF FDAAA Medical Device User Fee Amendments of 2007 Sec. 201. Short title; references in title; finding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Subtitle A — Fees Related to Medical Devices Definitions. . . . . . . . . . . . . . . . . . . . . . . . . Authority to assess and use d ... more>>

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Documents > food and drug administration

Guidance for Industry Day Generic Drug Exclusivity Under the Hatch Waxman Amendments to the Federal Food Drug and Cosmetic Act

How FDA reviews drug names

Stemming drug errors from abbreviations

Drug errors involving Keppra and Kaletra

FDA s Role in Responding to Drug Shortages

Drug Safety Oversight Board Members

Irradiation of Food An FDA Perspective

Food Advisory Committee Food Biotechnology Subcommittee Meeting September

Pet Food Recalls List

Sterile Drug Process Inspections

Guidance for Industry and FDA Staff Intravascular Administration

Public Health Service Food and Drug Adminstration

Guidance for Industry Implementation of Section of the Food and Drug Administration Modernization Act of Elimination of Certain Labeling Requirements

Guidance for Industry Advisory Committees Implementing Section of the Food and Drug Administration Modernization Act

Medical Device Provisions Of the Food And Drug Administration Amendments Act Of Preliminary PDF