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Guidance for industry [[electronic resource] ] : fast track drug development programs, designation, development and application review
Guidance for industry [[electronic resource] ] : fast track drug development programs, designation, development and application review
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, , [2006]
Descrizione fisica 21 pages : digital, PDF file
Soggetto topico Drug development - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry
Record Nr. UNINA-9910698808403321
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, , [2006]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Guidance for industry [[electronic resource] ] : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance
Guidance for industry [[electronic resource] ] : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance
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 (16 pages)
Soggetto topico Drug development - Government policy - United States
Drug factories - Government policy - United States
Quality assurance - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry
Record Nr. UNINA-9910699126003321
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Guidance for industry [[electronic resource] ] : street drug alternatives
Guidance for industry [[electronic resource] ] : street drug alternatives
Pubbl/distr/stampa Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2000]
Descrizione fisica 1 online resource (4 unnumbered pages)
Soggetto topico Drugs of abuse
Alternative medicine - Government policy - United States
Drug development - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry
Record Nr. UNINA-9910699115103321
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2000]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Guidance for industry [[electronic resource] ] : population pharmacokinetics
Guidance for industry [[electronic resource] ] : population pharmacokinetics
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, , [1999]
Descrizione fisica 1 online resource (iii, 31 p)
Soggetto topico Population
Pharmacokinetics
Drug development - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry
Record Nr. UNINA-9910699246503321
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, , [1999]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Guidance for industry [[electronic resource] ] : manufacturing, processing, or holding active pharmaceutical ingredients
Guidance for industry [[electronic resource] ] : manufacturing, processing, or holding active pharmaceutical ingredients
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 online resource (iii, 53 pages)
Soggetto topico Drug development - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry
Record Nr. UNINA-9910699125703321
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
Opac: Controlla la disponibilità qui
Guidance for industry and FDA [[electronic resource] ] : current good manufacturing practice for combination products
Guidance for industry and FDA [[electronic resource] ] : current good manufacturing practice 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, , [2004]
Descrizione fisica 8 p : digital, PDF file
Soggetto topico Drug development - Government policy - United States
Chemotherapy, Combination - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry and FDA
Record Nr. UNINA-9910698837603321
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2004]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui
Medicaid Pharmaceutical Home Act of 2018 : report together with additional views (to accompany H.R. 5808) (including cost estimate of the Congressional Budget Office)
Medicaid Pharmaceutical Home Act of 2018 : report together with additional views (to accompany H.R. 5808) (including cost estimate of the Congressional Budget Office)
Pubbl/distr/stampa [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2018]
Descrizione fisica 1 online resource (36 pages)
Collana Report / 115th Congress, 2d session, House of Representatives
Soggetto topico Medicaid
Medicare
Drugs - Prescribing - United States - Management
Opioid abuse - Treatment - United States - Costs
Drug development - Government policy - United States
Drugs - Generic substitution - Government policy - United States
Soggetto genere / forma Legislative materials.
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Medicaid Pharmaceutical Home Act of 2018
Record Nr. UNINA-9910709757803321
[Washington, D.C.] : , : [U.S. Government Publishing Office], , [2018]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
PDUFA V [[electronic resource] ] : medical innovation, jobs, and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, July 7, 2011
PDUFA V [[electronic resource] ] : medical innovation, jobs, and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, July 7, 2011
Pubbl/distr/stampa Washington : , : U.S. G.P.O., , 2012
Descrizione fisica 1 online resource (iii, 165 pages) : illustrations
Soggetto topico Drug approval - United States
Drug development - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti PDUFA V
Record Nr. UNINA-9910702089503321
Washington : , : U.S. G.P.O., , 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Q8(R1) pharmaceutical development revision 1 [electronic resource]
Q8(R1) pharmaceutical development revision 1 [electronic resource]
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], , [2008?]
Descrizione fisica 1 online resource (14 pages) : illustrations (some color)
Soggetto topico Drug development - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Q8
Record Nr. UNINA-9910702187703321
[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], , [2008?]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui

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