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The Center for Food Safety Vol

Dr. Bernard Schwetz, D,VM, Ph.D. Acting Principal Deputy Commissioner U.S. Food, and Drug Administration Room1 4-71, Parklawn Building 5600 Fishers Lane Rockville, MD 20857 Re: food labeling complaint Dear Dr. Schwetz: The undersigned organizations are writing in res;onse to a letter sent to you, dated August’14th, 2001, The regarding labels on foo ... more>>

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Food and Color Additive Petitions 92S 0251

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>>

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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>>

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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>>

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Drug Allergy

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Center for Food Safety Vol

THE CE.NTER FOR FOOD SAFETY . , ProtecNn*~* \ Health, 5600 Fishers Lane Rockville, MD 20857 Washington, DC 20204 -Washington, DC 20204 Re: Food Additive Petition 9M4697, Use of ionizing radiation for pre-processed nieat anh po&y; both raw and pre-processed vegetables, fruits and tither agricultural, products’ of plant origin; and certain mult ... more>>

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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>>

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Food Safety on the Home Front

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>>

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U S Department of Justice Drug Enforcement Administration

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FOOD AND DRUG ADMINISTRATION Center For Biologics Evaluation CroFab

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>>

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The Food Allergy Anaphylaxis Network Vol

Fairfax,VA 22030-2208 August 20,2002 Docket No. 98N-0359 Public Comments The Food Allergy & Anaphylaxis Network 10400 Eaton Place, Suite 107 Fairfax, VA 22030-2208 Tel: (800) 929-4040 Fax: (703) 691-2713 E-mail: legisl@foodallergymail.org I. FAAN The Food Allergy & Anaphylaxis Network (FAAN) is submitting the following comments regarding CFSAN p ... more>>

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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>>

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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>>

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DEPARTMENT OF HEALTH HUMAN SERVICES Food and Drug Selected Enforcement Actions onUnapproved Drugs

DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD 20857 WARNING LETTER October 11, 2002 Mr. John Q. Adams Product: Humibid Capsules Pediatric 300 mg Dear Sir/Madam: This letter is written in reference to the marketing by your firm of Humibid Capsules Pediatric 300 mg, a single ingredient guaifenesin extended releas ... more>>