FDA Papers, Volume 5U.S. Food and Drug Administration, 1971 |
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Halaman 1
... treatment . The clinical in- vestigator testing the effectiveness and safety of a new drug in various age groups faces the additional - and emotionally charged - predicament implicit in the use of a drug in children that is untested in ...
... treatment . The clinical in- vestigator testing the effectiveness and safety of a new drug in various age groups faces the additional - and emotionally charged - predicament implicit in the use of a drug in children that is untested in ...
Halaman 4
... treating disease , and as such , they constitute one of our most im- portant resources for an effective health care system ... treatment in general hospitals are admitted because of serious drug reactions . It is also es- timated that ...
... treating disease , and as such , they constitute one of our most im- portant resources for an effective health care system ... treatment in general hospitals are admitted because of serious drug reactions . It is also es- timated that ...
Halaman 7
... treatment of these diseases are unlikely to have been tested in children . It is a cause for real concern , in view of the differences already known about drug metabolism in the pediatric age group and other differences that may be ...
... treatment of these diseases are unlikely to have been tested in children . It is a cause for real concern , in view of the differences already known about drug metabolism in the pediatric age group and other differences that may be ...
Halaman 8
... treat the child with the conventional drug ? Let us say the child's diagnosis is Haemophilus influenzae meningitis , sensitive ... treatment or prevention of the disease for which the drug is intended . In Phase 2 studies , the drug is ...
... treat the child with the conventional drug ? Let us say the child's diagnosis is Haemophilus influenzae meningitis , sensitive ... treatment or prevention of the disease for which the drug is intended . In Phase 2 studies , the drug is ...
Halaman 35
... treated / Dyersburg , Tenn . 10/27/70 Butter / Kansas City , Kans . 10/16/70 Chilies , dried / Vernon , Calif . , and Los Angeles , Calif . 10/30/70 Cornhusks / Tucson , Ariz . 9/14/70 Cornmeal , yellow , enriched / Gadsden , Ala . 9/28 ...
... treated / Dyersburg , Tenn . 10/27/70 Butter / Kansas City , Kans . 10/16/70 Chilies , dried / Vernon , Calif . , and Los Angeles , Calif . 10/30/70 Cornhusks / Tucson , Ariz . 9/14/70 Cornmeal , yellow , enriched / Gadsden , Ala . 9/28 ...
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action Agency Animal Drug approved article contained article's botulism Bureau Calif Charged chemical Commissioner of Food Consent decree authorized consumer Cosmetic Act court cyclamate decree authorized release decree ordered destruction Default decree ordered Department devices director Dist District Drug Administration Drug Application effective Fair Packaging false and misleading FDA PAPERS FDA's Federal Food feed firm food additive Food and Drug Hazardous Substances Health held for sale held under insanitary industry ingredient injuries insanitary conditions inspection inspectors interstate commerce investigation involved Labeling Act Laboratories manufacturing practice ment microbiologist misbranded misleading claims National Notices of Judgment Office Packaging and Labeling packed under insanitary percent pesticide Pharmaceutical prepared and packed problem quantity of contents radiation regulations reported rodent Salmonella samples Sanitation seizure shellfish shipment shipped standard studies sumer tablets tion toys U.S. Customhouse Vibrio parahaemolyticus violation vitamin X-ray York
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Halaman 6 - But how are men to call upon him in whom they have not believed? And how are they to believe in him of whom they have never heard? And how are they to hear without a preacher?
Halaman 52 - Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, or while held for sale (whether or not the first sale) after shipment in interstate commerce...
Halaman 38 - The true distinction is between the delegation of power to make the law, which necessarily involves a discretion as to what it shall be, and conferring authority or discretion as to its execution; to be exercised under and in pursuance of the law. The first cannot be done. To the latter no valid objection can be made.
Halaman 2 - The commission may cause to be published, from time to time, reports summarizing all judgments, decrees and court orders which have been rendered under this act, including the nature of the charge and the disposition thereof. (b) The...
Halaman 1971-2 - false advertisement" means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may...
Halaman 2 - The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this Act, including the nature of the charge and the disposition thereof. (b) The Secretary may also cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this section shall be construed to...
Halaman 1971-6 - ... rabbits, rats and mice. Adverse fetal effects (increased resorptions, decreased fetal weight) were noticed only at very high parenteral doses that produced maternal toxicity. The relevance to the human is not known. Since there is no experience in pregnant women who have received this drug, safety in pregnancy has not been established and its use in pregnancy is not recommended.
Halaman 38 - The true distinction, therefore, is, between the delegation of power to make the law, which necessarily involves a discretion as to what it shall be, and conferring an authority or discretion as to its execution to be exercised under and in pursuance of the law.
Halaman 38 - Whenever the law draws a line there will be cases very near each other on opposite sides. The precise course of the line may be uncertain, but no one can come near it without knowing that he does so, if he thinks, and if he does so it is familiar to the criminal law to make him take the risk.