FDA's approval of the Today contraceptive sponge: hearing before a subcommittee of the Committee on Government Operations, House of Representatives, Ninety-eighth Congress, first session, July 13, 1983U.S. Government Printing Office, 1984 - 520 pages |
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Common terms and phrases
2,4-toluenediamine absorption agents animals applicant's application approval assay body weight Cancer carcinogenic cardiotoxicity cell chain length chemical chemist clinical compounds concentration congenital congenital disorders containing contraceptive sponge cosmetic detection detergents diamine diet dioxane dogs dosage dose effect emesis ethylene oxide evaluation exposure FDA's female finished sponges foam Food g/kg/day hepatocellular carcinomas HPLC human implanted indicated ingredients irritation labeling liver male mammary tumors Mantel manufacture material mercury metabolism method mice microgram per sponge monkey mouse mutagenicity myocardial nonoxynol-9 Nonoxynols nonyl 20d Nonylphenol octoxynol Panel percent polymer polyurethane pregnancy prepolymer procedure quantitative question rabbits rats reported risk assessment safety Schering significant skin Sobel specific sperm spermicide studies subcommittee submitted substances surfactants Table Ted Weiss TEMPLE teratogenicity tissue Today contraceptive sponge Today sponge toxicity transformation Triton tumors Tween 60 vaginal spermicides vitro VLI Corporation WEISS Weston women
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Page 195 - FR 16636) that this action is of a type that does not individually or cumulatively have a significant effect on the human • environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Page 96 - M. The development of carcinoma in liver of rats treated with m-toluylenediamine and the synergistic and antagonistic effects with other chemicals.
Page 122 - My colleagues and I will be happy to attempt to answer any questions you may have...
Page 229 - Administration (FDA) is preparing new recommendations for manufacturers of plasma derivatives and for establishments collecting plasma or blood. This is an interim measure to protect recipients of blood products and blood until specific laboratory tests are available. 3. Studies should be conducted to evaluate screening procedures for their effectiveness in identifying and excluding plasma and blood with a high probability of transmitting AIDS. These procedures should include specific laboratory...
Page 132 - Mr. Chairman, this concludes my formal statement. I will be happy to answer any questions you may have. GENERAL INVESTIGATIONS Senator STENNIS. We will insert the justification for "General Investigations
Page 23 - Modification of treatment schedules in the management of advanced mouse leukemia with amethopterin.
Page 3 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof...
Page 25 - Sanford, KK, and Earle, WR Studies of nutrient media for tissue cells in vitro. I: A proteinfree chemically defined medium for cultivation of strain L cells.
Page 195 - ... with the Hearing Clerk docket number found in brackets in the heading of this document.
Page 27 - GAYDOS, LA, FREIREICH, EJ, MANTEL, N.: The quantitative relation between platelet count and hemorrhage in patients with acute leukemia. New Engl.