Results 31 to 40 of about 757,641 (252)
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
Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the Approval Bottleneck [PDF]
, 2009 Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts, can save consumers billions of dollars per year. The Hatch-Waxman Act, which governs the introduction
Patel, Ankur N.
core +1 more source
Pediatric Blood &Cancer, EarlyView.ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen +23 more
wiley +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
Drug approval processes: A case study of rivaroxaban
Archives of Pharmacy Practice, 2013 Rivaroxaban, a Xa inhibitor, was recently approved (March 2013) in the setting of post-acute coronary syndromes (ACS) by the European Medicine Agency. This is in contrast to not being approved by the Food and Drug Agency in the United States for the same
Sally A Arif, Zainab Bilfaqi
doaj +1 more source
Disease modification in osteoarthritis; pathways to drug approval
Osteoarthritis and Cartilage Open, 2020 Summary: Objective: To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market. Design: Summary of a one day workshop held in Washington,
Jeffrey N. Katz +7 more
doaj +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
Pediatric Blood &Cancer, EarlyView.ABSTRACT Background Oral mucositis is a common and debilitating side effect of childhood cancer and stem cell transplant treatments. It affects the quality of life of children and young people (CYP) and places a strain on services. Photobiomodulation is recommended for oral mucositis prevention in international guidance but is poorly implemented in UK ...
Claudia Heggie +4 more
wiley +1 more source
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
Pediatric Blood &Cancer, EarlyView.ABSTRACT Background An international Delphi panel of experts developed consensus statements to delineate the circumstances where the risks of dexamethasone as an antiemetic do and do not outweigh its benefits. Procedure Experts in supportive care of pediatric patients were invited to participate.
Negar Shavandi +20 more
wiley +1 more source