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FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals [[electronic resource]]
| FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2008] |
| Descrizione fisica | 15 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - Evaluation - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA and industry actions on premarket approval applications |
| Record Nr. | UNINA-9910704829503321 |
| [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for FDA reviewers [[electronic resource] ] : premarket notification submissions for transfer sets (excluding sterile connecting sets)
| Guidance for FDA reviewers [[electronic resource] ] : premarket notification submissions for transfer sets (excluding sterile connecting sets) |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | i, 3 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - Evaluation - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for FDA reviewers |
| Record Nr. | UNINA-9910698826103321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Innovation in America [[electronic resource] ] : opportunities and obstacles : hearing before the Subcommittee on Competitiveness, Innovation, and Export Promotion of the Committee on Commerce, Science, and Transportation, United States Senate, One Hundred Eleventh Congress, second session, June 22, 2010
| Innovation in America [[electronic resource] ] : opportunities and obstacles : hearing before the Subcommittee on Competitiveness, Innovation, and Export Promotion of the Committee on Commerce, Science, and Transportation, United States Senate, One Hundred Eleventh Congress, second session, June 22, 2010 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2011 |
| Descrizione fisica | 1 online resource (iii, 82 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Technological innovations - Economic aspects - United States
Entrepreneurship - Government policy - United States Medical innovations - United States Medical instruments and apparatus industry - United States Medical instruments and apparatus - Evaluation - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Innovation in America |
| Record Nr. | UNINA-9910703299003321 |
| Washington : , : U.S. G.P.O., , 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Premarket approval application modular review [[electronic resource]]
| Premarket approval application modular review [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2003] |
| Descrizione fisica | 14 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - Evaluation - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698835203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2003] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Real-time premarket approval application (PMA) supplements [[electronic resource]]
| Real-time premarket approval application (PMA) supplements [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2006] |
| Descrizione fisica | 7 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - Evaluation - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Real-time premarket approval application |
| Record Nr. | UNINA-9910698846003321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
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Medical instruments and apparatus - Evaluation - Government policy - United States
(5)
- Entrepreneurship - Government policy - United States (1)
- Medical innovations - United States (1)
- Medical instruments and apparatus industry - United States (1)
- Technological innovations - Economic aspects - United States (1)