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FY ... performance report to the President and the Congress for the Prescription Drug User Fee Act of 1992 as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 [[electronic resource]]
| FY ... performance report to the President and the Congress for the Prescription Drug User Fee Act of 1992 as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, Md.], : Food and Drug Administration, Dept. of Health and Human Services |
| Descrizione fisica | electronic text, volumes : HTML, digital, PDF file |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States Drugs - United States - Testing |
| Formato | Materiale a stampa  |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910696381603321 |
| [Rockville, Md.], : Food and Drug Administration, Dept. of Health and Human Services | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : preparation of IDEs and INDs for products intended to repair or replace knee cartilage
| Guidance for industry [[electronic resource] ] : preparation of IDEs and INDs for products intended to repair or replace knee cartilage |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2007] |
| Descrizione fisica | i, 16 pages : digital, PDF file |
| Soggetto topico |
Cartilage
Medical instruments and apparatus - United States - Evaluation Drugs - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698876303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : nonclinical safety evaluation of pediatric drug products
| Guidance for industry [[electronic resource] ] : nonclinical safety evaluation of pediatric drug products |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] |
| Descrizione fisica | 1 electronic resource (22 pages) |
| Soggetto topico |
Drugs - United States - Testing
Pediatrics - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696959203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : nonclinical safety evaluation of drug or biologic combinations
| Guidance for industry [[electronic resource] ] : nonclinical safety evaluation of drug or biologic combinations |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] |
| Descrizione fisica | 1 electronic resource (13 pages) : charts |
| Soggetto topico |
Drugs - United States - Testing
Biologicals - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696966603321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : photosafety testing
| Guidance for industry [[electronic resource] ] : photosafety testing |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2003] |
| Descrizione fisica | 1 online version (21 pages) : charts |
| Soggetto topico |
Photobiology
Drugs - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696958503321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2003] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs)
| Guidance for industry [[electronic resource] ] : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs) |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2002] |
| Descrizione fisica | i, 22 pages : digital, PDF file |
| Soggetto topico |
Electronic filing systems - United States
Drugs - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698829503321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : PAC-ATLS : postapproval changes, analytical testing laboratory sites
| Guidance for industry [[electronic resource] ] : PAC-ATLS : postapproval changes, analytical testing laboratory sites |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1998] |
| Descrizione fisica | 1 electronic resource (3 pages) |
| Soggetto topico |
Drugs - United States - Testing
Laboratories - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910697097503321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1998] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and review staff [[electronic resource] ] : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route
| Guidance for industry and review staff [[electronic resource] ] : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2008] |
| Descrizione fisica | 1 electronic resource (8 pages) |
| Soggetto topico | Drugs - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and review staff |
| Record Nr. | UNINA-9910696963303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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An inquiry into the ImClone cancer-drug story : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, second session, June 13 and October 10, 2002
| An inquiry into the ImClone cancer-drug story : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, second session, June 13 and October 10, 2002 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2002 |
| Descrizione fisica | 1 online resource (iii, 759 pages) : illustrations |
| Soggetto topico |
Cetuximab - Testing
Drugs - United States - Testing Insider trading in securities - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Inquiry into the ImClone cancer-drug story |
| Record Nr. | UNINA-9910708376003321 |
| Washington : , : U.S. Government Printing Office, , 2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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News along the pike
| News along the pike |
| Pubbl/distr/stampa | Rockville, Md., : Center for Drug Evaluation and Research |
| Descrizione fisica | 1 online resource (volumes) |
| Soggetto topico |
Drugs - Research - United States
Drugs - United States - Testing Drugs - Research Drugs - Testing |
| Soggetto genere / forma | Periodicals. |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910695726103321 |
| Rockville, Md., : Center for Drug Evaluation and Research | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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