Results 31 to 40 of about 931,067 (298)
Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]
, 2005 Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core +1 more source
Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. [PDF]
, 2008 BackgroundPrevious studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results.
Bacchetti, Peter +2 more
core +3 more sources
Pediatric Blood &Cancer, EarlyView.ABSTRACT Blinatumomab has been shown to be highly effective for patients with pediatric B‐ALL and has recently become standard of care therapy. Due to its past use in the clinical trial setting, there is limited information available about real‐world administration.
Katelyn Oranges +12 more
wiley +1 more source
Sometimes the Silence Can Be like the Thunder: Access to Pharmaceutical Data at the FDA [PDF]
, 2006 Those committed to the free exchange of scientific information have long complained about various restrictions on access to the FDA\u27s pharmaceutical data and the resultant restrictions on open discourse.
Ankelhed, Daniel +2 more
core +2 more sources
, 2014 [Excerpt] The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice.
Cohen, I. Glenn, Price, W. Nicholson, II
core +1 more source
The need for a system view to regulate artificial intelligence/machine learning-based software as medical device [PDF]
, 2020 Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans.
Babic, Boris +3 more
core +3 more sources
Pediatric Blood &Cancer, EarlyView.ABSTRACT Objective To evaluate selumetinib exposure using therapeutic drug monitoring (TDM) in pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PN), assess interpatient pharmacokinetic variability, and explore the relationship between drug exposure, clinical response, and adverse effects.
Janka Kovács +8 more
wiley +1 more source
Valid cardiac biochemical markers. Part II
Кардиоваскулярная терапия и профилактика, 2020 This publication is a continuation of the review of cardiac biomarkers approved by the Food and Drug Administration (USA), including analysis of prospective research, clinical trials and meta-analyses.
N. G. Gumanova +4 more
doaj +1 more source
Pediatric Blood &Cancer, EarlyView.ABSTRACT Background Blinatumomab is a bispecific T‐cell engager approved for the treatment of pediatric B‐cell acute lymphoblastic leukemia (B‐ALL). Outpatient home infusion reduces hospitalization burden and optimizes resource utilization, but is logistically challenging.
Angela Parra del Riego +10 more
wiley +1 more source
npj VaccinesNeonates and young infants are known to have limited responses to pediatric vaccines due to reduced germinal center formation. Extended vaccine antigen dosing was previously shown to expand germinal center formation and improve humoral responses in adult
Leda Lotspeich-Cole +6 more
doaj +1 more source