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 11638
... regulations in the Federal Register , which also provided for a 60 - day period of comments from the public , a period later extended for 30 days . These comments bring to mind the book written some years ago by Richard Harris which ...
... regulations in the Federal Register , which also provided for a 60 - day period of comments from the public , a period later extended for 30 days . These comments bring to mind the book written some years ago by Richard Harris which ...
Page 11642
... regulations . These regulations specify the basic standards the manufacturer must adhere to in order to control his production process . Stringent process con- trol is essential to the manufacture of high quality drugs . Considerable ...
... regulations . These regulations specify the basic standards the manufacturer must adhere to in order to control his production process . Stringent process con- trol is essential to the manufacture of high quality drugs . Considerable ...
Page 11643
... regulations for specific pro- cesses such as the production of large volume paranterals , tablets , or capsules , medicinal gases , and radiopharmaceuticals . Specific GMP regulations are also being drafted for manufacturers of bulk ...
... regulations for specific pro- cesses such as the production of large volume paranterals , tablets , or capsules , medicinal gases , and radiopharmaceuticals . Specific GMP regulations are also being drafted for manufacturers of bulk ...
Page 11647
... regulations will be published in the near future , probably the end of April or May as a proposal , and they will def- initely appear before the MAC regulations are published as a final order . Specific procedures will be proposed for ...
... regulations will be published in the near future , probably the end of April or May as a proposal , and they will def- initely appear before the MAC regulations are published as a final order . Specific procedures will be proposed for ...
Page 11650
... regulations . Mr. Kelley explained that Ayerst had selected 200 of their key representatives , each of whom is to solicit letters of opposition from five pharmacists . He also explained that you would personally present the 1000 letters ...
... regulations . Mr. Kelley explained that Ayerst had selected 200 of their key representatives , each of whom is to solicit letters of opposition from five pharmacists . He also explained that you would personally present the 1000 letters ...
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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.