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Antitrust concerns and the FDA approval process : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017
| Antitrust concerns and the FDA approval process : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018 |
| Descrizione fisica | 1 online resource (iv, 51 pages) |
| Soggetto topico |
Drugs - United States - Testing
Drug approval - United States Drugs - Safety regulations - United States Medical instruments and apparatus - Safety regulations - United States Generic drugs - United States Competition - United States Antitrust law - United States Antitrust law Competition Drug approval Drugs - Safety regulations Drugs - Testing Generic drugs Medical instruments and apparatus - Safety regulations |
| Soggetto genere / forma |
Legislative hearings.
Rules. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Antitrust concerns and the FDA approval process |
| Record Nr. | UNINA-9910709758903321 |
| Washington : , : U.S. Government Publishing Office, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Food and Drug enforcement standards for medical devices : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and 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, September 14, 1995
| Food and Drug enforcement standards for medical devices : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and 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, September 14, 1995 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 1997 |
| Descrizione fisica | 1 online resource (v, 231 pages) : illustrations |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Medical instruments and apparatus - Standards - United States Administrative procedure - United States Administrative procedure Medical instruments and apparatus - Safety regulations Medical instruments and apparatus - Standards |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Food and Drug enforcement standards for medical devices |
| Record Nr. | UNINA-9910706247203321 |
| Washington : , : U.S. Government Printing Office, , 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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The GMP letter
| The GMP letter |
| Pubbl/distr/stampa | Washington, : Washington Business Information |
| Disciplina |
344.73/042
347.30442 |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Medical instruments and apparatus Medical instruments and apparatus - Safety regulations |
| Soggetto genere / forma | Periodicals. |
| Soggetto non controllato | Medical & Hospital Legislation - U.S. |
| ISSN | 1930-3971 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Good manufacturing practices letter |
| Record Nr. | UNISA-996417388703316 |
| Washington, : Washington Business Information | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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The GMP letter
| The GMP letter |
| Pubbl/distr/stampa | Washington, : Washington Business Information |
| Disciplina |
344.73/042
347.30442 |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Medical instruments and apparatus Medical instruments and apparatus - Safety regulations |
| Soggetto genere / forma | Periodicals. |
| Soggetto non controllato | Medical & Hospital Legislation - U.S. |
| ISSN | 1930-3971 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Good manufacturing practices letter |
| Record Nr. | UNINA-9910389176803321 |
| Washington, : Washington Business Information | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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The impact of medical device and drug regulation on innovation, jobs, and patients [[electronic resource] ] : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011
| The impact of medical device and drug regulation on innovation, jobs, and patients [[electronic resource] ] : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2012 |
| Descrizione fisica | 1 online resource (iii, 116 pages) |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Drug approval - United States Medical instruments and apparatus industry - California Pharmaceutical industry - California Drug approval Medical instruments and apparatus industry Medical instruments and apparatus - Safety regulations Pharmaceutical industry |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Impact of medical device and drug regulation on innovation, jobs, and patients |
| Record Nr. | UNINA-9910701840703321 |
| Washington : , : U.S. G.P.O., , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical device cybersecurity for engineers and manufacturers / / Axel Wirth, Christopher Gates, Jason Smith
| Medical device cybersecurity for engineers and manufacturers / / Axel Wirth, Christopher Gates, Jason Smith |
| Autore | Wirth Axel |
| Pubbl/distr/stampa | Norwood, Massachusetts : , : Artech House, , 2020 |
| Descrizione fisica | 1 online resource (303 pages) |
| Disciplina | 338.476817610973 |
| Collana | Artech House Information Security and Privacy Series |
| Soggetto topico |
Medical instruments and apparatus industry
Medical instruments and apparatus - Safety regulations Computer security |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-63081-816-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Why secure medical devices? -- 2. Establishing a cybersecurity focus -- 3. Supply chain management -- 4. Medical device manufacturers' development cycle -- 5. Security in production and sales -- 6. Medical device manufacturer postmarket lifecycle -- 7. HDO lifecycle -- 8. Documentation and artifacts -- 9. Organizational development of roles and responsibilities -- 10. Security technology, tools, and practices -- 11. Select topics/deep dives -- Glossary -- References -- About the authors -- Contributors -- Index. |
| Record Nr. | UNINA-9910511669103321 |
Wirth Axel
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| Norwood, Massachusetts : , : Artech House, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical device cybersecurity for engineers and manufacturers / / Axel Wirth, Christopher Gates, Jason Smith
| Medical device cybersecurity for engineers and manufacturers / / Axel Wirth, Christopher Gates, Jason Smith |
| Autore | Wirth Axel |
| Pubbl/distr/stampa | Norwood, Massachusetts : , : Artech House, , 2020 |
| Descrizione fisica | 1 online resource (303 pages) |
| Disciplina | 338.476817610973 |
| Collana | Artech House Information Security and Privacy Series |
| Soggetto topico |
Medical instruments and apparatus industry
Medical instruments and apparatus - Safety regulations Computer security |
| ISBN |
1-5231-4598-6
1-63081-816-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Why secure medical devices? -- 2. Establishing a cybersecurity focus -- 3. Supply chain management -- 4. Medical device manufacturers' development cycle -- 5. Security in production and sales -- 6. Medical device manufacturer postmarket lifecycle -- 7. HDO lifecycle -- 8. Documentation and artifacts -- 9. Organizational development of roles and responsibilities -- 10. Security technology, tools, and practices -- 11. Select topics/deep dives -- Glossary -- References -- About the authors -- Contributors -- Index. |
| Record Nr. | UNINA-9910794306003321 |
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Wirth Axel
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| Norwood, Massachusetts : , : Artech House, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical device cybersecurity for engineers and manufacturers / / Axel Wirth, Christopher Gates, Jason Smith
| Medical device cybersecurity for engineers and manufacturers / / Axel Wirth, Christopher Gates, Jason Smith |
| Autore | Wirth Axel |
| Pubbl/distr/stampa | Norwood, Massachusetts : , : Artech House, , 2020 |
| Descrizione fisica | 1 online resource (303 pages) |
| Disciplina | 338.476817610973 |
| Collana | Artech House Information Security and Privacy Series |
| Soggetto topico |
Medical instruments and apparatus industry
Medical instruments and apparatus - Safety regulations Computer security |
| ISBN |
1-5231-4598-6
1-63081-816-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Why secure medical devices? -- 2. Establishing a cybersecurity focus -- 3. Supply chain management -- 4. Medical device manufacturers' development cycle -- 5. Security in production and sales -- 6. Medical device manufacturer postmarket lifecycle -- 7. HDO lifecycle -- 8. Documentation and artifacts -- 9. Organizational development of roles and responsibilities -- 10. Security technology, tools, and practices -- 11. Select topics/deep dives -- Glossary -- References -- About the authors -- Contributors -- Index. |
| Record Nr. | UNINA-9910809326503321 |
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Wirth Axel
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| Norwood, Massachusetts : , : Artech House, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical device guidelines and regulations handbook / / edited by Prakash Srinivasan Timiri Shanmugam [and three others]
| Medical device guidelines and regulations handbook / / edited by Prakash Srinivasan Timiri Shanmugam [and three others] |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2022] |
| Descrizione fisica | 1 online resource (382 pages) |
| Disciplina | 610.284 |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations
Biomedical engineering |
| ISBN | 3-030-91855-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910564693603321 |
| Cham, Switzerland : , : Springer, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical devices : protecting patients and promoting innovation : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... November 15, 2011
| Medical devices : protecting patients and promoting innovation : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... November 15, 2011 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (iii, 70 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Medical instruments and apparatus - Standards - United States Medical instruments and apparatus - Safety regulations Medical instruments and apparatus - Standards |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Medical devices |
| Record Nr. | UNINA-9910705464203321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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