Competitive problems in the drug industry: hearings before Subcommittee on Monopoly and Anticompetitive Activities of the Select Committee on Small Business, United States Senate, Ninety-first Congress, first session ... |
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Page 11636
... Determine Criteria for Defining Categories of Medical Items . Attachment E : GSA Order ( ADM 5420.46 Dated Feb. 3 , 1975 ) , Subject : Establishment of the Interagency Medical and Non- perishable Subsistence Supply Management Committee ...
... Determine Criteria for Defining Categories of Medical Items . Attachment E : GSA Order ( ADM 5420.46 Dated Feb. 3 , 1975 ) , Subject : Establishment of the Interagency Medical and Non- perishable Subsistence Supply Management Committee ...
Page 11641
... determine the lowest price at which erythromycin was generally available to pharmacists throughout the country . Then we would have a determination as to whether or not the lowest available price had the same bioequiva- lency ...
... determine the lowest price at which erythromycin was generally available to pharmacists throughout the country . Then we would have a determination as to whether or not the lowest available price had the same bioequiva- lency ...
Page 11642
... determine whether the plan is operating in com- pliance with the Good Manufacturing Practices regulations . These regulations specify the basic standards the manufacturer must adhere to in order to control his production process ...
... determine whether the plan is operating in com- pliance with the Good Manufacturing Practices regulations . These regulations specify the basic standards the manufacturer must adhere to in order to control his production process ...
Page 11643
... Another thing we are doing is the surveillance of marketed drugs to determine whether they are adhering to compendial standards or to the standards that are established in new drug COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY 11643.
... Another thing we are doing is the surveillance of marketed drugs to determine whether they are adhering to compendial standards or to the standards that are established in new drug COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY 11643.
Page 11648
... determined that a drug has a bioequivalency problem ? Would it be determined on the basis of a scientific study or individual complaints ? Secretary WEINBERGER . No , scientific studies . Dr. Schmidt may want to elaborate on that . Dr ...
... determined that a drug has a bioequivalency problem ? Would it be determined on the basis of a scientific study or individual complaints ? Secretary WEINBERGER . No , scientific studies . Dr. Schmidt may want to elaborate on that . Dr ...
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Common terms and phrases
actual acquisition cost agencies antisubstitution laws APhA average wholesale price bioavailability bioequivalence brand name central CHAIRMAN competitive Defense develop Digoxin dispensing Drug Administration drug product Drug Research Board effective erythromycin established Food and Drug formulary Gaylord Nelson GORDON Government Government-wide hospital implementation inspection Interagency Labs local purchases MAC price MAC program MAC regulations Manufacturing Practices Maximum Allowable Cost Medicaid MEDICAL AND NONPERISHABLE medical items Medicare meeting ment MICHELOTTI patient percent Pharmaceutical pharmacists pharmacy physician PITTMAN prednisone prescribed present problems procurement professional proposed regulations purchasing quality assurance quality assurance program recommendations reimbursement resolution responsibility savings SCHMIDT Secretary WEINBERGER selection Small Business Sorett specific standards statement STETLER subcommittee substitution laws Supply Management Committee Tablets task group therapeutic equivalence tion TRYGSTAD WHITWORTH
Popular passages
Page 12087 - Since many agencies, including the Food and Drug Administration in the Department of Health, Education and Welfare, in which the appellant was employed, have nothing to do with national security, the Act of 1950 has nothing to do with them. The authorization to bring "other...
Page 12159 - Register, to be In the public interest in connection with the performance of duties imposed on that agency by law.
Page 11700 - I AM PLEASED TO BE HERE TODAY AND TO HAVE THE OPPORTUNITY TO ASK QUESTIONS OF SECRETARY JACKSON.
Page 12328 - Engineering before the Subcommittee on Health of the Senate Committee on Labor and Public Welfare, 94th Cong., 1st Sess.
Page 12055 - The hearing need not be conducted according to technical rules relating to evidence and witnesses. Any relevant evidence shall be admitted if it is the sort of evidence on which responsible persons are accustomed to rely in the conduct of serious affairs, regardless of the existence of any common law or statutory rule which might make improper the admission of such evidence over objection in civil actions.
Page 11663 - OF THE SELECT COMMITTEE ON SMALL BUSINESS, Washington, DC The subcommittee met, pursuant to notice, at 10 am, in room 2221.
Page 11925 - Action is pleased to have the opportunity to present its views on the $12.7 billion supplemental appropriation for America's efforts in Vietnam.
Page 11732 - STATEMENT OF ALEXANDER M. SCHMIDT, MD, COMMISSIONER, FOOD AND DRUG ADMINISTRATION; ACCOMPANIED BY J. RICHARD GROUT, MD, DIRECTOR, BUREAU OF DRUGS; PETER BARTON »HUTT, ASSISTANT GENERAL COUNSEL; LLOYD B. TEPPER, MD, ASSOCIATE COMMISSIONER FOR SCIENCE; BARRETT SCOVILLE, MD, ACTING DIRECTOR OF THE DIVISION OF BUREAU OF NEUROt PHARMACOLOGICAL PROJECTS; AND ROBERT WETHERELL, DIRECTOR, OFFICE OF LEGISLATIVE SERVICES Dr.
Page 12055 - substantial evidence" means : Evidence consisting of adequate and well controlled investigations, including clinical investigations by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts 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 labeling...
Page 12054 - The means employed shall be such as to allow, to the extent practicable, eligible persons to secure health care in the same manner employed by the public generally, and without discrimination or segregation based purely on their economic disability.