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Entry threats and pricing in the generic drug industry [[electronic resource] /] / Brett Wendling, Steven Tenn
| Entry threats and pricing in the generic drug industry [[electronic resource] /] / Brett Wendling, Steven Tenn |
| Autore | Wendling Brett |
| Pubbl/distr/stampa | Washington, DC : , : Bureau of Economics, Federal Trade Commission, , [2010] |
| Descrizione fisica | 1 online resource (27 pages) : digital, PDF file |
| Altri autori (Persone) | TennSteven |
| Collana | Working paper |
| Soggetto topico |
Generic drugs - Prices - United States
Pharmaceutical industry - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910699567003321 |
Wendling Brett
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| Washington, DC : , : Bureau of Economics, Federal Trade Commission, , [2010] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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EpiPen price increases : how regulatory barriers inhibit pharmaceutical competition : field hearing of the Subcommittee on Children and Families of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session on examining EpiPen price increases, focusing on how regulatory barriers inhibit pharmaceutical competition, October 7, 2016 (Lexington, KY)
| EpiPen price increases : how regulatory barriers inhibit pharmaceutical competition : field hearing of the Subcommittee on Children and Families of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session on examining EpiPen price increases, focusing on how regulatory barriers inhibit pharmaceutical competition, October 7, 2016 (Lexington, KY) |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018 |
| Descrizione fisica | 1 online resource (iii, 43 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Prescription pricing - United States
Drugs - Law and legislation - United States Pharmaceutical industry - United States Competition - United States Drug delivery devices - Prices - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | EpiPen price increases |
| Record Nr. | UNINA-9910711623503321 |
| Washington : , : U.S. Government Publishing Office, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner
| Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (295 p.) |
| Disciplina |
343.7307/86151
542.1 |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States |
| Soggetto genere / forma | Electronic books. |
| Soggetto non controllato | Current Good Manufacturing Practices |
| ISBN |
1-280-44808-3
9786610448081 0-470-23938-7 0-471-78478-8 0-471-78477-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. |
| Record Nr. | UNINA-9910143411103321 |
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Bliesner David M
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| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner
| Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (295 p.) |
| Disciplina |
343.7307/86151
542.1 |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States |
| Soggetto non controllato | Current Good Manufacturing Practices |
| ISBN |
1-280-44808-3
9786610448081 0-470-23938-7 0-471-78478-8 0-471-78477-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. |
| Record Nr. | UNINA-9910830871703321 |
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Bliesner David M
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| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner
| Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (295 p.) |
| Disciplina |
343.7307/86151
542.1 |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States |
| Soggetto non controllato | Current Good Manufacturing Practices |
| ISBN |
1-280-44808-3
9786610448081 0-470-23938-7 0-471-78478-8 0-471-78477-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. |
| Record Nr. | UNINA-9910841397903321 |
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Bliesner David M
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| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Experiences of health maintenance organizations with pharmacy benefit management companies
| Experiences of health maintenance organizations with pharmacy benefit management companies |
| Pubbl/distr/stampa | [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 1997 |
| Descrizione fisica | 1 online resource (82 unnumbered pages) : illustrations |
| Soggetto topico |
Medicare
Medicaid Health maintenance organizations - United States Pharmaceutical services - United States Pharmaceutical policy - United States Pharmaceutical industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910707435003321 |
| [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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FDA and the drug development process [[electronic resource] ] : how the agency ensures that drugs are safe and effective
| FDA and the drug development process [[electronic resource] ] : how the agency ensures that drugs are safe and effective |
| Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2002] |
| Descrizione fisica | 1 sheet : digital, PDF file |
| Collana |
Just the facts
Publication |
| Soggetto topico |
Drug development
Drugs - Testing Pharmaceutical industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA and the drug development process |
| Record Nr. | UNINA-9910695574603321 |
| Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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FDA medical product approvals : hearing before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, August 8, 1995
| FDA medical product approvals : hearing before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, August 8, 1995 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 1997 |
| Descrizione fisica | 1 online resource (iii, 55 pages) |
| Soggetto topico |
Medical instruments and apparatus industry - United States
Pharmaceutical industry - United States Government paperwork - United States Government paperwork Medical instruments and apparatus industry Pharmaceutical industry |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA medical product approvals |
| Record Nr. | UNINA-9910706250503321 |
| Washington : , : U.S. Government Printing Office, , 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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FDA-approved bargain drugs [[electronic resource] ] : generic products must meet high standards
| FDA-approved bargain drugs [[electronic resource] ] : generic products must meet high standards |
| Edizione | [Rev. Dec. 2003.] |
| Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2003] |
| Descrizione fisica | 1 sheet : digital, PDF file |
| Collana |
Just the facts
Publication |
| Soggetto topico |
Generic drugs
Drugs - Testing Pharmaceutical industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA-approved bargain drugs |
| Record Nr. | UNINA-9910695574703321 |
| Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2003] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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FDAnews device daily bulletin
| FDAnews device daily bulletin |
| Pubbl/distr/stampa | Falls Church, Va., : Washington Business Information |
| Disciplina | 615 |
| Soggetto topico |
Pharmaceutical industry - United States
Food industry and trade - United States Food industry and trade Pharmaceutical industry |
| Soggetto genere / forma | Periodicals. |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996207885703316 |
| Falls Church, Va., : Washington Business Information | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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