Hearings, Reports and Prints of the Senate Select Committee on Small Business, Dij. 33-34U.S. Government Printing Office, 1978 |
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Rezultati 1 - 5 od 41.
Stranica 15576
... Luther , Sterling Drug Co. , and T. E. Byers , Associate Director for Compliance , FDA .. Memorandum of telephone conversation dated February 5 , 1976 , between James Luther , Sterling Drug Co. , and Bernard T. Loftus , Division of Drug ...
... Luther , Sterling Drug Co. , and T. E. Byers , Associate Director for Compliance , FDA .. Memorandum of telephone conversation dated February 5 , 1976 , between James Luther , Sterling Drug Co. , and Bernard T. Loftus , Division of Drug ...
Stranica 15576
... Luther , Sterling Drug Co. , and T. E. Byers , Associate Di- rector for Compliance , FDA . Memorandum of telephone conversation dated February 5 , 1976 , between James Luther , Sterling Drug Co. , and Bernard T. Loftus , Division of ...
... Luther , Sterling Drug Co. , and T. E. Byers , Associate Di- rector for Compliance , FDA . Memorandum of telephone conversation dated February 5 , 1976 , between James Luther , Sterling Drug Co. , and Bernard T. Loftus , Division of ...
Stranica 15577
... Luther , Sterling Drug Co. , and Bernard T. Loftus , Division of Drug Manufacturing , Bureau of Drugs , FDA ... . Summary of findings of Mary E. Stewart , Investigator , Philadelphia Branch , Food and Drug Administration , dated July 23 ...
... Luther , Sterling Drug Co. , and Bernard T. Loftus , Division of Drug Manufacturing , Bureau of Drugs , FDA ... . Summary of findings of Mary E. Stewart , Investigator , Philadelphia Branch , Food and Drug Administration , dated July 23 ...
Stranica 15885
... Luther Vice President - Director Sterling Drug , Inc. New York , New York . Bernard T. Loftus , Director Division of Drug Manufacturing Bureau of Drugs Injunction Mr. Luther called at 4:07 P.M. He asked me if any decision had been made ...
... Luther Vice President - Director Sterling Drug , Inc. New York , New York . Bernard T. Loftus , Director Division of Drug Manufacturing Bureau of Drugs Injunction Mr. Luther called at 4:07 P.M. He asked me if any decision had been made ...
Stranica 15889
... monitored by FDA Puffalo , H.Y. submitted 12/3/75 Diana J. Kolaitis Investigator New York District MEMORANDUM OF TELEPHONE CONVERSATION BETWEEN : Mr. James Luther December COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY 15889.
... monitored by FDA Puffalo , H.Y. submitted 12/3/75 Diana J. Kolaitis Investigator New York District MEMORANDUM OF TELEPHONE CONVERSATION BETWEEN : Mr. James Luther December COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY 15889.
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action Agency Ampicillin antisubstitution approved Aspirin batch BIOAVAILABILITY bioequivalence brand name Buffalo District Bureau of Drugs California Capsules Code codeine complaint Compliance contained contract Contractor cost COUNT MFRNAME COUNT DEPARTMENT OF HEALTH digoxin Director dispensed dosage forms Drug Administration drug applications drug list Drug Manufacturing E.R. Squibb Erythromycin evaluation facility FDA's Federal Federal Food FILE firm firm's Food and Drug GORDON indicated Injection inspection labeling Laboratories Labs legislation letter Luther Manufacturing Practice Medi-Cal Medi-Cal program meet MFR/RECALLER MFRNAME COUNT MFRNAME mg/cap Milledgeville Norwich package patient penicillin percent pharmaceutical pharmacies pharmacists physicians plant propoxyphene prosecution quality assurance Quality Control recall record regulations Rensselaer reports request responsible Rx Init samples Senator NELSON specific Squibb & Sons standards statement sterile Sterling Drug STETLER substitution laws Tablets testing tetracycline Volume Purchase Plan VPP drugs Wescoe wholesalers York
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Stranica 16356 - for training including apprenticeship. F. The Contractor shall, in all solicitations or advertisements for employees placed by or on behalf of the Contractor state that all qualified applicants will receive consideration for employment without discrimination based on age, race, color, creed, national origin, sex, or condition of physical
Stranica 16557 - Its history and current pattern of abuse. 5. The scope, duration and significance of abuse. 6. What, If any, risk there is to the public health. 7- Its psychic or physiological dependence liability. 8. Whether the substance is an Immediate precursor of a substance already controlled under this subchapter. 121 USC
Stranica 16566 - and (b)(2). 109. 21 USC § 812. The findings required for Schedules II and IV are as follows: (2) Schedule II (A) The drug or other substance has a high potential for abuse. (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. CC) Abuse of
Stranica 16874 - (2) that has 'a currently accepted medical use in treatment in the United States, or a currently accepted medical use with severe restrictions,' and "(3) for which abuse may lead to 'severe psychological or physical dependence.
Stranica 16557 - To provide guidance to the Attorney General, the statute further states that the Attorney General's inquiry must include an evaluation of the following factors: 1. Its actual or relative potential for abuse. 2. Scientific evidence of Its pharmacological effect, If known. 3. The state of current scientific knowledge regarding the drug or other substance.
Stranica 16260 - CONGRESS, IST SESSION WASHINGTON, D,C. NOVEMBER 15, 1977 American Pharmaceutical Association 2215 Constitution Avenue, NW Washington, DC 20037 (202) 628-4410 MR. CHAIRMAN; MEMBERS OF THE SUBCOMMITTEE: I AM DR. WILLIAM S, APPLE, EXECUTIVE DiRECTOR OF THE AMERICAN PHARMACEUTICAL ASSOCIATION, THE NATIONAL PROFESSIONAL SOCIETY OF PHARMACISTS IN THE UNITED STATES. ACCOMPANYING ME
Stranica 16561 - Report to Drug Addiction Committee 20 April 1956, Addendum to Minutes of the 17th Meeting of the Committee on Drug Addiction and Narcotics of the National Research Council," Washington, DC 30-31 January 1956. 2. See, eg, Gruber, CM, "Codeine Phosphate, Propoxyphene
Stranica 16773 - PROPOXYPHENE :; Mr. Chairman, in your letter of invitation you asked me to comment on the reasons for the sustained popularity of propoxyphene as an analgesic ;:. in view of Its limited effectiveness. The answer to this question Is complex and involves a number of factors. First, I would point out that a significant number of
Stranica 16855 - 4) :65, 1967. 9. Lim, RKS, et al.: Site of Action of Narcotic and Non-Narcotic Analgesics Determined by Blocking Bradykinin-Evoked Visceral Pain, Arch. Int. Pharmacodyn., 152(1-2) : 25-58,1964. 10. Lorenzetti, OJ, and Sancilio, LF: Morphine Dependent Rats as a Model for Evaluating Potential Addiction Liability of Analgesic Compounds, Arch. Int. Pharmacodyn., 183:391-402,1970.
Stranica 16198 - be sterile which are adulterated within the meaning of 21 USC 351(a)(2)(B) in that the methods used in and the facilities and controls used for the manufacturing, processing, packing, or holding of said articles do not conform to and