Results 31 to 40 of about 1,710,685 (294)
Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries
Revista Panamericana de Salud Pública, 2021 Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are ...
Carlos E. Durán +6 more
doaj +1 more source
An analysis of common ethical justifications for compassionate use programs for experimental drugs [PDF]
, 2016 BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years.
Raus, Kasper
core +1 more source
Urine Screening for Opiod and Illicit Drugs in the Total Joint Arthroplasty Population [PDF]
, 2020 Introduction. Recent studies have shown an increase in post-operative orthopaedic complications associated with pre-operative opioid use. It is, therefore, important to know if patients use opioids before scheduled surgery.
Bhargava, Tarun +6 more
core +2 more sources
Communication and Freedom: An Althusserian Reading of Media-Government Relations [PDF]
, 2000 This essay draws on the work of French philosopher Louis Althusser, particularly his contributions to the development of ideology, in an assessment of the relationship between communication ana freedom.
Brennen, Bonnie
core +2 more sources
The importance of greater speed in drug development for advanced malignancies
Cancer Medicine, 2018 It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life‐years potentially saved if selected agents were ...
David J. Stewart +9 more
doaj +1 more source
Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine [PDF]
, 2017 The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation ...
Resek, John F., Ph.D.
core +2 more sources
Pediatric Blood &Cancer, EarlyView.ABSTRACT Introduction Characterizing stressful events reported by childhood cancer survivors experienced throughout the lifespan may help improve trauma‐informed care relevant to the survivor experience. Methods Participants included 2552 survivors (54% female; 34 years of age) and 469 community controls (62% female; 33 years of age) from the St.
Megan E. Ware +13 more
wiley +1 more source
Ethical Issues in the Drug Approval Process [PDF]
, 2013 The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
core +1 more source
Pediatric Blood &Cancer, EarlyView.ABSTRACT Purpose Patient activation—encompassing knowledge, confidence, and skills in managing individual's health—is a cornerstone of person‐centered care. However, its significance among childhood, adolescent, and young adult cancer survivors (CAYACS) remains unexplored. This article examines the application of the 13‐item Patient Activation Measure (
Charlotte Demoor‐Goldschmidt +12 more
wiley +1 more source
Pediatric Blood &Cancer, EarlyView.ABSTRACT Neuroblastoma is the most common extracranial solid tumor in early childhood. Its clinical behavior is highly variable, ranging from spontaneous regression to fatal outcome despite intensive treatment. The International Society of Pediatric Oncology Europe Neuroblastoma Group (SIOPEN) Radiology and Nuclear Medicine Specialty Committees ...
Annemieke Littooij +11 more
wiley +1 more source