Results 61 to 70 of about 135,991 (315)

Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items [PDF]

The AAPS Journal, 2014
Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS).
Huyi, Zhang, Haitao, Li, Wei, Song, Diandian, Shen, David, Skanchy, Kun, Shen, Robert A, Lionberger, Susan M, Rosencrance, Lawrence X, Yu   +8 more
openaire   +2 more sources

Analysis of a Permanent Prohibition on Implementing the Major Health Care Legislation Enacted in March 2010 [PDF]

, 2011
[Excerpt] This letter discusses many of the potential effects of a permanent ban on the use of appropriated funds to implement the health care laws and, where possible, provides information on whether those effects would increase or decrease direct ...
Elmendorf, Douglas W
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Anti‐CD19 CAR T Cells in Autoimmune Encephalitis: Inflammation Controlled, Neurodegeneration Unchecked?

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Just recently, successful chimeric antigen receptor (CAR) T cell therapy was reported in the first patient with refractory, anti‐diacylglycerol lipase alpha (DAGLA) antibody‐mediated autoimmune encephalitis, achieving partial clinical remission.
Dimitrios Mougiakakos, Marwa Al‐Dubai, Denise Walther, Dominic Borie, Jan D. Lünemann, Marc Pawlitzki, Sven G. Meuth, Solveig Henneicke, Stefan Vielhaber, Stefanie Schreiber   +9 more
wiley   +1 more source

The Economic Impact of Clinical Research in an Italian Public Hospital: The Malignant Pleural Mesothelioma Case Study [PDF]

International Journal of Health Policy and Management, 2018
Background The current economic constraints cause hospital management to use the available public resources as rationally as possible. At the same time, there is the necessity to improve current scientific knowledge.
Roberto Ippoliti, Greta Falavigna, Federica Grosso, Antonio Maconi, Lorenza Randi, Gianmauro Numico   +5 more
doaj   +1 more source

Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure. [PDF]

, 2019
BACKGROUND: Moderate and moderately severe renal impairment are common in patients with heart failure and reduced ejection fraction, but whether beta-blockers are effective is unclear, leading to underuse of life-saving therapy.
Andersson, B, Anker, SD, Beta-Blockers in Heart Failure Collaborative Group, Böhm, M, Cleland, JGF, Coats, AJS, Damman, K, Flather, MD, Gill, SK, Holmes, J, Kjekshus, J, Kotecha, D, Manzano, L, McMurray, JJV, Packer, M, Redon, J, Rigby, AS, Rosano, G, Ruschitzka, F, van Veldhuisen, DJ, von Lueder, TG, Wedel, H, Wikstrand, J   +22 more
core   +8 more sources

Efficacy of Inebilizumab in N‐MOmentum Trial Participants With or Without Prior Immunosuppressants

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT This post hoc analysis examined the impact of prior immunosuppressants on the long‐term efficacy and safety of inebilizumab, a cluster of differentiation 19+ B‐cell–depleting monoclonal antibody, in participants with aquaporin‐4–seropositive neuromyelitis optica spectrum disorder from the N‐MOmentum trial (NTC02200770).
Bruce A. C. Cree, Beatrice Suero, Sarah Walsh, Romain Marignier, John W. Lindsey, Ho Jin Kim, Dewei She, Daniel Cimbora, Dustin Cavida, Friedemann Paul   +9 more
wiley   +1 more source

Determinants of Audit Fees: Evidence from Pharmaceutical and Chemical Industry of Bangladesh

, 2019
The main objective of this study is to find out the factors that determine the audit fees in the listed pharmaceuticals and chemicals companies of Bangladesh. The study is conducted on 21 listed companies in the pharmaceuticals and chemicals industry during the period of 2015 to 2018.
Md. Noor Hossain, Raihan Sobhan
openaire   +2 more sources

Clinical, histological, and serological predictors of renal function loss in lupus nephritis.

Arthritis Care &Research, Accepted Article.
Objective Kidney survival is the ultimate goal in lupus nephritis (LN) management, but long‐term predictors remain inadequately studied, requiring long‐term follow‐up. This study aimed to identify baseline and early longitudinal predictors of kidney survival in the Accelerating Medicines Partnership LN longitudinal cohort.
Shangzhu Zhang, Laurence Magder, Daniel Goldman, Judith A. James, Joel M Guthridge, Carla Guthridge, Peter Izmirly, Jill P Buyon, H.Michael Belmont, Richard A. Furie, Noa Schwartz, Chaim Putterman, Jennifer L. Barnas, Jennifer H. Anolik, Sarah French, Maria Dall'era, Avi Z. Rosenberg, Jeffrey Hodgin, Dawit S. Demeke, the Accelerating Medicines Partnership RA/SLE Network, Michelle Petri, Andrea Fava   +21 more
wiley   +1 more source

Cross-sectional analysis of financial relationships between board certified allergists and the pharmaceutical industry in Japan

BMC Medical Ethics
Background Financial interactions between pharmaceutical companies and physicians lead to conflicts of interest. This study examines the extent and trends of non-research payments made by pharmaceutical companies to board-certified allergists in Japan ...
Anju Murayama, Yuki Senoo
doaj   +1 more source

Strangers in the night:a comparative study on the socio-legal difficulties of importing America’s Bayh-Dole legislation to South African universities [PDF]

, 2019
In 2008, the South African parliament passed the Intellectual Property Rights from Publicly Financed Research and Development Act, which came into effect on 2 August 2010.
Kouletakis, Jade
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