Counterfeit Bulk Drugs: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Sixth Congress, Second Session, June 8 and October 3, 2000, Volume 4 |
From inside the book
Results 1-5 of 100
Page 1
... FDA had linked the adverse reactions of 155 American patients to gentamicin sulfate made by Long March Pharmaceutical ... FDA's inspection revealed data integrity problems and other seri- ous deficiencies with Long March . Despite FDA ...
... FDA had linked the adverse reactions of 155 American patients to gentamicin sulfate made by Long March Pharmaceutical ... FDA's inspection revealed data integrity problems and other seri- ous deficiencies with Long March . Despite FDA ...
Page 2
... FDA leadership and weaknesses in FDA's import system appear to have left the American public vulnerable to dangerous drugs from abroad . As some FDA officials have noted , the prevailing high prices and potential protits from ...
... FDA leadership and weaknesses in FDA's import system appear to have left the American public vulnerable to dangerous drugs from abroad . As some FDA officials have noted , the prevailing high prices and potential protits from ...
Page 3
... FDA's Office of Criminal Investigations ( OCI ) received an OCI - requested package of information from FDA's Center for Drug Evaluation and Research ( CDER ) Division of Epidemiology and Surveillance . That package of information ...
... FDA's Office of Criminal Investigations ( OCI ) received an OCI - requested package of information from FDA's Center for Drug Evaluation and Research ( CDER ) Division of Epidemiology and Surveillance . That package of information ...
Page 4
... FDA outside of OCI . In an August 1996 memorandum , the FDA's Forensic Chemistry Center noted : " We have detected human and animal , bulk and dosage counterfeit pharmaceuticals .... We literally have no control over bulk drugs that ...
... FDA outside of OCI . In an August 1996 memorandum , the FDA's Forensic Chemistry Center noted : " We have detected human and animal , bulk and dosage counterfeit pharmaceuticals .... We literally have no control over bulk drugs that ...
Page 5
... FDA Foreign Product Working Group had begun to target the Long March gentamicin sulfate issue . According to the minutes of the September 1 , 1998 meeting of FDA's Foreign Products Working Group , it was the consensus of the group to ...
... FDA Foreign Product Working Group had begun to target the Long March gentamicin sulfate issue . According to the minutes of the September 1 , 1998 meeting of FDA's Foreign Products Working Group , it was the consensus of the group to ...
Other editions - View all
Common terms and phrases
adverse events Agency Agency's agents APIs approved authentic BAKER Bliley bulk pharmaceutical BURR CDER certificates of analysis Chairman chemical China FEI Committee companies compliance counterfeit APIs counterfeit bulk drugs counterfeit drugs counterfeit pharmaceuticals Criminal Investigations Cytotec database developed DINGELL documents domestic Drug Administration drug imports drug listing drug products enforcement entry evaluation FDA's finished drug Flavine Flavine International Food and Drug foreign drug manufacturers foreign inspections foreign manufacturers Forensic Chemistry Forensic Chemistry Center Fred Upton gentamicin sulfate HENNEY human drug identified import alert import inspectors imported counterfeit issue Italy FEI labeling Long March manufacturing practices medicines mifepristone misoprostol OASIS Office of Criminal oxytetracycline Pharmaceutical Factory pharmaceutical products pharmacies potential prescription drugs problem prosecution regulations regulatory reimportation reports requirements safety samples shipments shipped specific STRICKLAND STUPAK substandard testing U.S. agent U.S. Customs Service United
Popular passages
Page 155 - ... punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.
Page 9 - Please note that, for the purpose of responding to these requests, the terms "records" and "relating" should be interpreted in accordance with the Attachment to this letter.
Page 269 - We appreciate your continued interest in these issues, and I will be happy to answer questions. [The prepared statement of Hon.
Page 327 - There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers. closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
Page 127 - counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer,...
Page 10 - records" is to be construed in the broadest sense and shall mean any written or graphic material, however produced or reproduced, of any kind or description, consisting of the original and any non-identical copy (whether different from the original because of notes made on or attached to such copy or otherwise) and drafts and both sides thereof, whether printed or recorded electronically or magnetically or stored in any type of data bank, including, but not limited to, the following: correspondence,...
Page 306 - MD Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Dear Dr.
Page 359 - It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
Page 10 - relating," "relate," or "regarding" as to any given subject means anything that constitutes, contains, embodies, identifies, deals with, or is in any manner whatsoever pertinent to that subject, including but not limited to records concerning the preparation of other records.
Page 10 - ... statistical statements, drafts, contracts, agreements, purchase orders, invoices, confirmations, telegraphs, telexes, agendas, books, notes, pamphlets, periodicals, reports, studies, evaluations, opinions, logs, diaries, desk calendars, appointment books, tape recordings, video recordings, e-mails, voice mails, computer tapes, or other computer stored matter, magnetic tapes, microfilm, microfiche, punch cards, all other records kept by electronic, photographic, or mechanical means, charts, photographs,...