Guidance for industry [[electronic resource] ] : IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] |
Descrizione fisica | 1 online resource (8 pages) |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Clinical trials - Government policy - United States Cancer - Treatment - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910699051203321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Guidance for industry [[electronic resource] ] : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information |
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 electronic resource (24 pages) |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Drug approval - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910696915403321 |
[Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2003] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Guidance for industry [[electronic resource] ] : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] |
Descrizione fisica | 1 electronic resource (10 pages) |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Biologicals - United States Drug approval - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910696912703321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (charging for investigational products) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698919003321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (use of investigational products when subjects enter a second institution) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698911803321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators ("off-label" and investigational use of marketed drugs, biologics, and medical devices) |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
Descrizione fisica | 1 electronic text : HTML file |
Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Information sheet |
Record Nr. | UNINA-9910698911403321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Right to try : hearing before the Committee on Homeland Security and Governmental Affairs, United States Senate, One Hundred Fourteenth Congress, second session : connecting patients to new and potential life saving treatments, February 25, 2016 ; exploring a right to try for terminally ill patients, September 22, 2016 |
Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2017 |
Descrizione fisica | 1 online resource (iv, 329 pages) : illustrations |
Collana | S. hrg. |
Soggetto topico |
Medical policy - United States
Patients - Civil rights - United States Clinical trials - Government policy - United States Medicine, Experimental - Government policy - United States Medical innovations - Government policy - United States |
Soggetto genere / forma | Legislative hearings. |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Right to try |
Record Nr. | UNINA-9910705860703321 |
Washington : , : U.S. Government Publishing Office, , 2017 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|