Regulation of Medical Devices: (intrauterine Contraceptive Devices) Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-third Congress, First Session |
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A. H. Robins abortion advertising associated birth control bleeding BROWN of Michigan BROWN of Ohio cervical cervix Chairman clinical complications Congress continuation rate copper Dalkon Shield DATE Director doctor Drug Administration dysmenorrhea effective endometrium evaluation experience expulsion Family Planning FDA's Federal Trade Commission fertility Food and Drug Fort Polk FOUNTAIN FREUND GOLDHAMMER Gynec Hospital HUTT infection insertion Intrauterine Contraceptive Devices intrauterine devices IUD's JENNINGS labeling legislation letter Lippes loop MADRY Majzlin Spring manufacturers medical devices memorandum metrorrhagia Mishell months nulliparous Ob-Gyn Obstetrics and Gynecology oral contraceptives Ostergard patients pelvic pelvic inflammatory disease percent perforation physician pill Planned Parenthood Population Council pregnancy rate problems procedure question recommended regulation removal Saf-T-Coil safety Segal standards statement statistics sterile subcommittee T-Cu THAIN THOMSEN Tietze tion users uterine cavity uterus VANDER JAGT women
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Page 171 - ... (6) For a reagent, a means by which the user may be assured that the product meets appropriate standards of identity, strength, quality and purity at the time of use. This shall be provided, both for the product as provided and for any resultant reconstituted or mixed product, by including on the label one or more of the following: (i) An expiration date based upon the stated storage instructions.
Page 171 - label" means a display of written, printed, or graphic matter upon the immediate container of any substance; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears...
Page 171 - label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The...
Page 166 - Part 1 Regulations for the enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
Page 11 - An ad hoc committee (1) in 1963 advised that "comprehensive and critical" studies to look into the possibility be conducted. Nevertheless, little was done in this direction, despite the great increase in the use of these potent drugs. By the time the Advisory Committee on Obstetrics and Gynecology of the Food and Drug Administration began to prepare its first report on the oral contraceptives in 1965, it was evident that an epidemiologic study was even more urgently needed than in 1963.
Page 174 - Provided, however, That in the case of containers too small or otherwise unable to accommodate a label with sufficient space to bear all such information, but which are packaged within an outer container from which they are removed for...
Page 361 - ... action in areas where both agencies have a concern and the actions of one agency may affect proceedings by the other.
Page 177 - Interested persons may, within 90 days after publication hereof in the FEDERAL REGISTER, file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 6-88, 5600 Fishers Lane, Rockville, MD 20852.
Page ii - ... prices of many common retail products. (2) This confusion has resulted from improper packaging and labeling practices by American manufacturers and packagers of consumer products. (3) The remedy for these improper practices is a change to the federal law by which greater authority would be given to the Food and Drug Administration and the Federal Trade Commission in the regulation of packaging and labeling practices. These assumptions are supported by the testimony of many witnesses in the .Senate...
Page 176 - A summary of the data and views setting forth the medical rationale and purpose (or lack thereof) for the drug and its ingredients and the scientific basis (or lack thereof) for the conclusion that the drug and its ingredients have been proven safe and effective for the Intended use. If there is an absence of controlled studies in the material submitted, an explanation as to why such studies are not considered necessary must be included.