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1 |
Material Type: Artigo na Web
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2 |
Material Type: Livro
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Overdose how excessive government regulation stifles pharmaceutical innovationRichard Allen EpsteinNew Haven Yale University Press cop. 2006Localização: FEA - Fac. Econ. Adm. Contab. e Atuária ACERVO DELFIM NETTO (A28.25.14 )(Acessar) |
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Material Type: Artigo
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A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)Gnanasakthy, Ari ; Barrett, Amy ; Evans, Emily ; D'Alessio, Denise ; Romano, Carla (DeMuro)Value in health, 2019-02, Vol.22 (2), p.203-209 [Periódico revisado por pares]United States: Elsevier IncTexto completo disponível |
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4 |
Material Type: Artigo
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Model‐Informed Drug Development: A Regulatory Perspective on ProgressZhu, Hao ; Huang, Shiew Mei ; Madabushi, Rajanikanth ; Strauss, David G. ; Wang, Yaning ; Zineh, IssamClinical pharmacology and therapeutics, 2019-07, Vol.106 (1), p.91-93 [Periódico revisado por pares]United StatesTexto completo disponível |
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Material Type: Artigo
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Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VIDarrow, Jonathan J ; Avorn, Jerry ; Kesselheim, Aaron S Hamel, Mary BethThe New England journal of medicine, 2017-12, Vol.377 (23), p.2278-2286 [Periódico revisado por pares]United States: Massachusetts Medical SocietyTexto completo disponível |
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Material Type: Artigo
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Fluorine‐Containing Drugs Approved by the FDA in 2018Mei, Haibo ; Han, Jianlin ; Fustero, Santos ; Medio‐Simon, Mercedes ; Sedgwick, Daniel M. ; Santi, Claudio ; Ruzziconi, Renzo ; Soloshonok, Vadim A.Chemistry : a European journal, 2019-09, Vol.25 (51), p.11797-11819 [Periódico revisado por pares]Germany: Wiley Subscription Services, IncTexto completo disponível |
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Material Type: Artigo
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Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)Atreya, Chintamani ; Glynn, Simone ; Busch, Michael ; Kleinman, Steve ; Snyder, Edward ; Rutter, Sara ; AuBuchon, James ; Flegel, Willy ; Reeve, David ; Devine, Dana ; Cohn, Claudia ; Custer, Brian ; Goodrich, Raymond ; Benjamin, Richard J. ; Razatos, Anna ; Cancelas, Jose ; Wagner, Stephen ; Maclean, Michelle ; Gelderman, Monique ; Cap, Andrew ; Ness, PaulTransfusion, 2019-09, Vol.59 (9), p.3002-3025 [Periódico revisado por pares]Hoboken, USA: John Wiley & Sons, IncTexto completo disponível |
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Material Type: Artigo
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The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug SafetyCarpenter, Daniel ; Chattopadhyay, Jacqueline ; Moffitt, Susan ; Nall, ClaytonAmerican journal of political science, 2012-01, Vol.56 (1), p.98-114 [Periódico revisado por pares]Malden, USA: Blackwell Publishing IncTexto completo disponível |
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Material Type: Artigo
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External control arms in oncology: current use and future directionsMishra-Kalyani, P.S. ; Amiri Kordestani, L. ; Rivera, D.R. ; Singh, H. ; Ibrahim, A. ; DeClaro, R.A. ; Shen, Y. ; Tang, S. ; Sridhara, R. ; Kluetz, P.G. ; Concato, J. ; Pazdur, R. ; Beaver, J.A.Annals of oncology, 2022-04, Vol.33 (4), p.376-383 [Periódico revisado por pares]England: Elsevier LtdTexto completo disponível |
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10 |
Material Type: Artigo
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Observed Potential Cross-Contamination in Retail DelicatessensHolst, Meghan M. ; Brown, Laura G. ; Viveiros, Brendalee ; Faw, Brenda V. ; Hedeen, Nicole ; Mckelvey, Wendy ; Nicholas, David ; Ripley, Danny ; Hammons, Susan R.Journal of food protection, 2021-06, Vol.84 (6), p.1055-1059 [Periódico revisado por pares]United States: Elsevier IncTexto completo disponível |