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Автор Henry, Veronica
Дата выпуска 1993
Формат application.pdf
Издатель Taylor & Francis Group
Копирайт Copyright Taylor and Francis Group, LLC
Название 1992 Le Tourneau award: Problems with Pharmaceutical Regulation in the United States
Тип research-article
DOI 10.1080/01947649309510932
Electronic ISSN 1521-057X
Print ISSN 0194-7648
Журнал Journal of Legal Medicine
Том 14
Первая страница 617
Последняя страница 639
Аффилиация Henry, Veronica; Associate, Kopff, Nardelli & Dopf
Выпуск 4
Библиографическая ссылка Dillman. 1991. Prescription Drug Approval and Terminal Diseases: Desperate Times Require Desperate Measures. Vand. L. Rev., 44: 925928
Библиографическая ссылка Nov. 1992. From Laboratory to Medicine Cabinet Nov., 16 Caring
Библиографическая ссылка Aug. 27 1990. PMA Lines Up with FDA Panel on Drug Reviews: Pharmaceutical Manufacturers Association, Food and Drug Administration,, Chemical Marketing Rep. Aug. 27, 7
Библиографическая ссылка Allan. 1992. A Primer of Drug Safety Surveillance: An Industry Perspective Part 1: Information Flow, New Drug Development, and Federal Regulations. J. Pharmacy Tech., July/Aug.: 164
Библиографическая ссылка 1993. FDA's 26 New Molecular Entity Approvals in 1992 Are Fewer than Record 30 NME Clearances in 1991 but Are Improvement Over Agency Performance from 1986–1990. F‐D‐C REPS.—(The Pink Sheet), Jan. 11: 9
Библиографическая ссылка 1993. New Drugs of 1992. Drug Topics, Feb. 8: 48
Библиографическая ссылка 1990. Drug Industry Claims FDA Route too Long: FDA Drug Approval Process. Chemical Marketing Rep., Jan. 22: 5
Библиографическая ссылка Johnson. 1984. Rx for Pharmaceuticals. Penton/IPC, Industry Week, Aug. 6: 32
Библиографическая ссылка Hayes. 1990. Safety Considerations in Product Development. Drug Safety, 5(Supp. 1): 24
Библиографическая ссылка Williams and Copelan. 1993. New Drugs for 1993. The Consultant Pharmacist, Mar.: 208
Библиографическая ссылка 1987. Fed. Reg., 52: 19,466
Библиографическая ссылка Miller and Young. 1989. The Drug Approval Process at the Food and Drug Administration: New Biotechnology as a Paradigm of a Science‐Based Activist Approach. Arch. Int. Med., 149: 655
Библиографическая ссылка Ziporyn. 1985. The Food and Drug Administration: How Those Regulations Came to Be. J.A.M.A., 254: 20392041
Библиографическая ссылка Dunn, C. 1938. Federal Food, Drug and Cosmetic Act, : 88
Библиографическая ссылка Nelson. 1988. Regulation of Investigational New Drugs: “Giant Step for the Sick and Dying?”. Geo. L.J., 77: 463468
Библиографическая ссылка Cavers. 1939. The Food, Drug and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provision. Law & Contemp. Probs., 6: 220
Библиографическая ссылка Farley. 1987. Benefit vs. Risk: How FDA Approves New Drugs. FDA Consumer, Dec.: 10 ‐Jan. 1988,
Библиографическая ссылка Richardson. 1987. The Orphan Drug Tax Credit: An Inadequate Response to an Ill‐Defined Problem. Am. J. Tax Pol'y, 6: 135143
Библиографическая ссылка Fed. Reg., 5341518
Библиографическая ссылка Rin‐Laures and Janofsky. 1991. Recent Development Concerning the Orphan Act. Harv. J.L. & Tech., 4: 269271
Библиографическая ссылка Marwick. 1988. FDA Seeks Swifter Approval of Drugs for Some Life‐Threatening or Debilitating Diseases. J.A.M.A., 260: 2976
Библиографическая ссылка Young. 1988. The FDA's New Procedures for the Use of Investigational Drugs in Treatment. J.A.M.A., 259: 22672268
Библиографическая ссылка Delaney. 1989. Patient Access to Experimental Therapy. J.A.M.A., 261: 2444
Библиографическая ссылка Sage. 1988. Drug Product Liability and Health Care Delivery Systems. Stan. L. Rev., 40: 989
Библиографическая ссылка Kolata. 1991. Patients Going Underground to Buy Experimental Drugs. N.Y. Times, Nov. 4: 1
Библиографическая ссылка Cotton. 1991. FDA “Pushing Envelope” on AIDS Drug. J.A.M.A., 266: 757
Библиографическая ссылка 1991. Regulators Set Faster Approval Process for a New Drug. Reuters Bus. Rep., Nov. 13
Библиографическая ссылка Gasbarro. 1990. The High Cost of Drugs Is a Bitter Pill to Take. Wash. Times, Dec. 3: M6
Библиографическая ссылка Waldholz. 1991. During 1980's Prescription Drug Prices Rose Almost 3 Times the Inflation Rate. Wall St. J., Sept. 25: B3
Библиографическая ссылка Iglehart. 1991. Health Policy Report: The Food and Drug Administration and Its Problems. New Eng. J. Med., 325: 217
Библиографическая ссылка Ballin. 1982. Regulation and Development of New Drugs. J.A.M.A., 247: 29952996
Библиографическая ссылка 1990. Panel Recommends Changes to Expedite Approval of Cancer, AIDS Drugs. Am. J. Hosp. Pharmacy, 47 Nov.: 24102411
Библиографическая ссылка 1990. See PHS Proposes “Parallel Track” for New AIDS Drugs. Pub. Health Rep., 105: 541
Библиографическая ссылка Nightingale. 1985. The Evolving Drug Approval Process: Challenges and Opportunities. Food, Drug & Cosm. L. J., 40: 499
Библиографическая ссылка Marwick. 1987. Proposal to Make Investigational New Drugs Available Without Clinical Trial Participation in Certain Cases Is Receiving Mixed Responses. J.A.M.A., 257: 3020
Библиографическая ссылка Cooper. 1989. Controlled Clinical Trials of AIDS Drugs: The Best Hope. J.A.M.A., 261: 2445
Библиографическая ссылка Mar. 9 1981. “Hearings Before the Subcommittee on Health and the Environment of the Comm. on Energy and Commerce on Orphan Drug Act”. Mar. 9, 97th Cong., 1st Sess. 49
Библиографическая ссылка Fed. Reg., 5219,467
Библиографическая ссылка Merz. 1988. Treatment INDs: Promising, Problematic. J.A.M.A., 259: 16071608
Библиографическая ссылка Anderson. 1989. Cancer and AIDS Groups Push for Changes in Drug Approval Process. J. Nat'l Cancer Inst., 81: 829
Библиографическая ссылка Wittes. 1988. Noninvestigational Uses of Investigational Drugs: Some Implications of FDA's Revised Regulations. J. Nat'l Cancer Inst., 80: 301
Библиографическая ссылка 1992. Prescription Drug User Fee Statute Enacted. J.A.M.A., 268: 3418
Библиографическая ссылка Conlan. 1993. Drug Industry R & D Spending Continues to Climb, PMA Reports. Drug Topics, Feb. 8: 96
Библиографическая ссылка 1992. New Drug Law to Speed Scientific Review. Nature, Oct. 15: 563
Библиографическая ссылка 1993. User Fee Invoices Will Go Out to Companies “Two Weeks” After President Signs Supplemental Appropriations Bill Authorizing Fee Collection, FDA's Veverka Says. F‐D‐C Rep. (The Pink Sheet), July 5: 5
Библиографическая ссылка 1992. Changes in FDA Drug Classification and Priority Review Policy. Am. J. Hosp. Pharmacy, 49 Oct.: 2386
Библиографическая ссылка Nov. 13 1991. Administration Acts to Speed Drug Approval,, Nov. 13, UPI.
Библиографическая ссылка 1992. Clinical Briefs: Approval for Broader Use of DDI. Am. Fam. Physician, 46 Dec.: 1841
Библиографическая ссылка 1991. Rushing DDI to Market. Time, Oct. 21: 83
Библиографическая ссылка 1992. Speeding Drug Ok's: Quayle's Plan for Accelerating Approvals by 40% Is Implemented by New Regulations. Am. Druggist, June: 12
Библиографическая ссылка Gupta. 1991. Venture Capital Funds Are Expected to Rise Sharply. Wall St. J., Nov. 27: B2
Библиографическая ссылка Gatty. 1993. Whatever Happened to User Fees and the FDA's Promise to Expedite New Drug Approvals?. Hosp. Formul., July: 656
Библиографическая ссылка McKercher. 1992. Issues in Health Policy: Pharmaceutical Research and Development. Clinical Therapeutics, Sept./Oct.: 762
Библиографическая ссылка Batterman. 1990. Brother Can You Spare a Drug: Should the Experimental Drug Distribution Standards Be Modified in Response to the Needs of Persons with AIDS?. Hofstra L. Rev., 19: 191219
Библиографическая ссылка Grossman. 1984. The Orphan Drug Act: Adoption or Foster Care?. Food, Drug & Cosm. L.J., 39: 128
Библиографическая ссылка Finkel. 1984. The Orphan Drug Act and the Federal Government's Orphan Products. Pub. Health Rep., 99 May/June: 313
Библиографическая ссылка Asbury. 1991. The Orphan Drug Act: The First 7 Years. J.A.M.A., 265: 893
Библиографическая ссылка Carter and Bennet. 1989. Developments in Orphan Drugs. Food, Drug & Cosm. L.J., 44: 627
Библиографическая ссылка June 26 1980. “Hearing Before the Subcomm. on Health and the Environment of the Comm. on Interstate and Foreign Commerce: Drug Regulation Reform‐Oversight (Orphan Drugs)”. June 26, 96th Cong., 2d Sess.
Библиографическая ссылка 1992. Orphan Drugs: The PMA's Latest Survey Shows an Increase in the Development of Drugs for Rare Disorders. Am. Druggist, June: 12
Библиографическая ссылка Shulman, Bienz‐Tadmor, Seo, DiMasi and Lasagna. 1992. Implementation of the Orphan Drug Act: 1983–1991. Food, Drug & Cosm. L.J., 47: 363365
Библиографическая ссылка Carey and Hamilton. 1990. These “Orphans” Don't Need Any Nurturing. Bus. Week, July 2: 38
Библиографическая ссылка 1991. 1991 Annual Survey: 176 Medicines in Testing for Rare Diseases. Orphan Drugs, : 1
Библиографическая ссылка Fed. Reg., 563338
Библиографическая ссылка Lawton. 1991. Controversy Under the Orphan Drug Act: Is Resolution on the Way?. Food, Drug & Cosm. L.J., 46: 327328–32.
Библиографическая ссылка 1991. Fed. Reg., 56: 33383346
Библиографическая ссылка Kenney. 1989. The Orphan Drug Act: Is It a Barrier to Innovation? Does It Create Unintended Windfalls?. Food, Drug & Cosm. L.J., 43: 627628
Библиографическая ссылка Thomas. 1990. Re‐assessing the Orphan Drug Act. Colum. J.L. & Soc. Probs., 23: 413433
Библиографическая ссылка 1991. Fed. Reg., 56: 33383346
Библиографическая ссылка 1991. Fed. Reg., 56: 33383345
Библиографическая ссылка 1991. Fed. Reg., 56: 33383345
Библиографическая ссылка Feb. 7 1990. “Hearings Before the House Subcomm. on Health and the Environment”. Feb. 7, 101st Cong., 2d Sess.
Библиографическая ссылка Chapman. 1990. Thalidomide Isn't the Only Risk in Drug Regulation. Chi. Trib., June 3: 3

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