FDA Papers, Volume 5

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U.S. Food and Drug Administration, 1971

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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.

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