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Bundling multiple devices or multiple indications in a single submission [[electronic resource]]
| Bundling multiple devices or multiple indications in a single submission [[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, , [2007] |
| Descrizione fisica | 14 pages : digital, PDF file |
| Soggetto topico |
Medical instruments and apparatus - United States - Evaluation
User charges - 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-9910698876103321 |
| 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, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
| Guidance for industry and FDA staff [[electronic resource] ] : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements |
| 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 | 11 pages : digital, PDF file |
| Soggetto topico |
Medical instruments and apparatus - United States - Evaluation
User charges - 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-9910698715003321 |
| [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 industry and FDA staff [[electronic resource] ] : expedited review of premarket submissions for devices
| Guidance for industry and FDA staff [[electronic resource] ] : expedited review of premarket submissions for devices |
| 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 | 12 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - United States - Evaluation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698714603321 |
| 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 industry and FDA staff [[electronic resource] ] : class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle
| Guidance for industry and FDA staff [[electronic resource] ] : class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2007] |
| Descrizione fisica | i, 6 pages : digital, PDF file |
| Soggetto topico |
Blood cells
Hemapheresis Separation (Technology) |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698900903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps)
| Guidance for industry and FDA staff [[electronic resource] ] : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps) |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2007] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Transplantation of organs, tissues, etc - Government policy - United States Cell transplantation - 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-9910698991703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : commercially distributed analyte specific reagents (ASRs), frequently asked questions
| Guidance for industry and FDA staff [[electronic resource] ] : commercially distributed analyte specific reagents (ASRs), frequently asked questions |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety : , : Center for Biologics Evaluation and Research, , [2007] |
| Descrizione fisica | 13 pages : digital, PDF file |
| Soggetto topico | Biological reagents |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698890503321 |
Guidance for industry and FDA staff [[electronic resource] ] : early development considerations for innovative combination products
| Guidance for industry and FDA staff [[electronic resource] ] : early development considerations for innovative combination products |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2006] |
| Descrizione fisica | 13 pages : digital, PDF file |
| Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Drug development - Government policy - United States Biological products - 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-9910698991403321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : application user fees for combination products
| Guidance for industry and FDA staff [[electronic resource] ] : application user fees for combination products |
| Pubbl/distr/stampa | [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2005] |
| Descrizione fisica | 15 pages : digital, PDF file |
| Soggetto topico |
User charges - Government policy - United States
Drug approval - Government policy - United States Chemotherapy, Combination |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698929103321 |
| [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
| Guidance for industry and FDA staff [[electronic resource] ] : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products, , [2004?] |
| Descrizione fisica | 7 pages : digital, PDF file |
| Soggetto topico |
Dispute resolution (Law)
Drug approval - Government policy - United States Chemotherapy, Combination |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910697010803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products, , [2004?] | ||
| 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 | ||
| ||
