FDA's Regulation of the New Drug Versed: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, Second Session, May 5 and 10, 1988, Volume 4
United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee
U.S. Government Printing Office, 1988 - 599 pages
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Page 51 - FOOD AND DRUG ADMINISTRATION PUBLIC HEALTH SERVICE DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE OH GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES MAY 5, 1988 FOR RELEASE ONLY UPON DELIVERY Mr.
Page 523 - ... shall appear in the upper left corner of the envelope. (2) The following statement is to appear in the far left third of the envelope in the type and size indicated and in reverse printing, centered in a red rectangle 3% inches wide and 2V4 inches high: IMPORTANT— ELECTRONIC PRODUCT RADIATION WARNING The statement shall be in three lines, all capitals, and centered. "Important" shall be in 36 point Gothic Bold type.
Page 377 - ... hospitalization, or is a congenital anomaly, cancer, or overdose. With respect to results obtained from tests in laboratory animals, a serious adverse drug experience includes any experience suggesting a significant risk for human subjects, including any finding of mutagenicity, teratogenicity, or carcinogenicity. 'Unexpected adverse experience...
Page 523 - USC 371, unless otherwise noted. SOURCE: 40 FR 13996, Mar. 27, 1975, unless otherwise noted. Subpart A — General Provisions § 200.5 Mailing of important information about drugs. Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required...
Page 377 - The sponsor shall notify FDA and all participating investigators in a written IND safety report of any adverse experience associated with use of the drug that is both serious and unexpected. Such notification shall be made as soon as possible and in no event later than 10 working days after the sponsor's initial receipt of the information. Each written notification shall bear prominent identification of its contents, ie, "IND Safety Report.
Page 458 - Severe systemic disturbance or disease from whatever cause, even though it may not be possible to define the degree of disability with finality...
Page 233 - Certification The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
Page 377 - The following definitions of terms apply to this section .Associated with, the use of the drug. There Is a reasonable possibility that the experience may have been caused by the drug. Disability. A substantial disruption of a person's ability to conduct normal life functions. Life-threatening adverse drug experi-ence. Any adverse drug experience...
Page 514 - BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE ON GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES DECEMBER 10, 1987 RELEASE ONLY UPON DELIVERY Food and Drug Administration Rockville MO 20857 Introduction Mr.
Page 524 - Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers. (a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory, warehouse, or establishment in which prescription drugs are manufactured, processed, packed, or held. (b) The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent...