FDA Regulation of Blood Safety: Notification, Recall, and Enforcement Practices : Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, First Session, June 5, 1997U.S. Government Printing Office, 1998 - 300 pages |
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accident reports adverse event reports albumin Anne Marie B372 Rayburn House Baxter blood and blood blood facilities blood products blood safety system CBER CBER's Centeon Chairman Christopher Shays CHESEMORE Christopher Shays Subcommittee compliance CONGRESS THE LIBRARY Creutzfeldt-Jakob disease Dear Chairman Shays District Office donors Enterobacter cloacae EPSTEIN error and accident factor Factor VIII FDA's Finley FRIEDMAN Government Reform hemophilia hepatitis House Office Building HTLV Human Resources industry infected inspection process inspections of plasma inspectors issue joint inspections licensed manufacturers MedWatch nation's blood supply Odwalla Office Building Washington ORA's Oversight Committee patient notification system percent plasma fractionators plasma pools plasma products primary immune deficiency problem product recalls RARY Rayburn House Office recommendations Reform and Oversight regulations regulatory Relations B372 Rayburn responsive blood safety RESS risk ROSLEWICZ saline contamination source plasma STEINHARDT Subcommittee on Human talk paper Thank transfusion withdrawal and recalls
Popular passages
Page 222 - Given these persistent and growing concerns about immunization safety, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recognized the need for an independent, expert group to address immunization safety in a timely and objective manner.
Page 263 - HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS, COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT, Washington, DC.
Page 163 - FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest.
Page 233 - II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Page 13 - ... for a very long period of time. A land acquisition program Is dynamic and subjected to constant forces which create necessity for change. With your permission. I will be pleased to furnish you with new estimates as they are updated as well as a full explanation on how the updating was accomplished. If there is any other way that I can be of assistance to you or your Subcommittee, I will appreciate your advising me. With kindest personal regards and best wishes, I am, Sincerely yours, GEORGE....
Page 12 - House Office Building, Washington, DC. 20515 DEAR MR. CHAIRMAN: I would like to take this opportunity...
Page 112 - This concludes my prepared statement, Mr. Chairman. I will be happy to answer any questions you or members of the committee might have.
Page 226 - In September 1996, FDA issued a final regulation on "Current Good Manufacturing Practices for Blood and Blood Components: Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection.
Page 147 - Practices (GMP) which cover such areas as organization and personnel; buildings and facilities; equipment; control of components, product containers and closures; production and process controls; packaging and labeling controls; holding and distribution; laboratory controls; records and reports; and licensing.
Page 107 - Regulations (CFK ) and its policies and recommendations through memorandums and letters, compliance manuals and the compliance program, compliance policy guides, and a guide for blood facility inspections. The requirements in the Public Health Service Act; the Food, Drug, and Cosmetic Act; and the CFR are the only mandatory requirements.