Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce: Food, Drug, and Related Law : Including Federal Food, Drug, and Cosmetic Act, Controlled Substances Act ...U.S. Government Printing Office, 1993 - 459 lappuses |
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1.5. rezultāts no 26.
79. lappuse
... patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent in- fringement could ...
... patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent in- fringement could ...
80. lappuse
... patent information has not been filed , ( ii ) that such patent has expired , ( iii ) of the date on which such patent will expire , or ( iv ) that such patent is invalid or will not be infringed by the manufacture , use , or sale of ...
... patent information has not been filed , ( ii ) that such patent has expired , ( iii ) of the date on which such patent will expire , or ( iv ) that such patent is invalid or will not be infringed by the manufacture , use , or sale of ...
81. lappuse
... patent information was required under subsection ( b ) or a patent was issued after the application was approved under such subsection , the holder of an approved application shall file with the Secretary , the patent num- ber and the ...
... patent information was required under subsection ( b ) or a patent was issued after the application was approved under such subsection , the holder of an approved application shall file with the Secretary , the patent num- ber and the ...
82. lappuse
... patent valid- ity and infringement and if the court decides that such patent is invalid or not infringed , the approval shall be made effective on the date of such court decision . In such an action , each of the parties shall ...
... patent valid- ity and infringement and if the court decides that such patent is invalid or not infringed , the approval shall be made effective on the date of such court decision . In such an action , each of the parties shall ...
83. lappuse
... patent infringement is commenced during the one - year period beginning forty - eight months after the date of the approval of the subsection ( b ) application , the thirty - month period referred to in subparagraph ( C ) shall be ...
... patent infringement is commenced during the one - year period beginning forty - eight months after the date of the approval of the subsection ( b ) application , the thirty - month period referred to in subparagraph ( C ) shall be ...
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accordance action active ingredient administrative agency amended animal drug animal feed appropriate approved new animal Attorney authorized certification clause color additive conduct contains controlled substance Controlled Substances Act court deemed distribution distributor drug application drug or device ecgonine effective date electronic product enactment established exemption expiration export Federal Food Federal Trade Commission fees filed forfeiture hearing individual infant formula investigations isomers issued labeling manufacturer marihuana ment narcotic narcotic drugs notice offense officer or employee oleomargarine paragraph patent penalty period person petition prescribed procedures proceedings promulgated proposed public health purposes reasonable recommendations records registration regulation request respect retary route of administration schedule III Secretary determines Secretary finds Secretary of Health sentence smokeless tobacco standard subchapter submitted subparagraph substance in schedule term of imprisonment thereof tion title 18 United States attorney United States Code unless violation
Populāri fragmenti
179. lappuse - ... file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order.
6. lappuse - ... generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
129. lappuse - ... that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling...
179. lappuse - Code. (2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the...
10. lappuse - The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
399. lappuse - The notice shall include (1) a statement of the time, place, and nature of public rule making proceedings; (2) reference to the legal authority under which the rule is proposed; and (3) either the terms or substance of the proposed rule or a description of the subjects and issues involved.
399. lappuse - This section applies, according to the provisions thereof, in every case of adjudication required by statute to be determined on the record after opportunity for an agency hearing...
45. lappuse - In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.
438. lappuse - Executive order; (2) related solely to the internal personnel rules and practices of an agency; (3) specifically exempted from disclosure by statute (other than section 552b of this title), provided that such statute (A) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (B) establishes particular criteria for withholding or refers to particular types of matters to be withheld...
416. lappuse - ... affect a member of the public; unless the materials are promptly published and copies offered for sale. To the extent required to prevent a clearly unwarranted invasion of personal privacy, an agency may delete identifying details when it makes available or publishes an opinion, statement of policy, interpretation, or staff manual or instruction. However, in each case the justification for the deletion shall be explained fully in writing.