EMA welcomes today’s two appellate judgments by the Court of Justice1 that confirmed, in clear and unambiguous terms, the right of citizens for access to clinical study and toxicology reports submitted to EMA for the purpose of the granting of a marketing authorisation for human and veterinary medicinal products. Source EMA “Transparency is an important feature of the Agency’s
Prof Murphy, leading authority on autism research at Kings College Hospital, says he is horrified that such a treatment is being offered. Lesley Curwen investigates the scientific promise of human stem cells, cells with superpowers that can become many different types of cells in our bodies from muscle cells to brain cells. Some can even
Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form. 2. Recruitment and Informed consent procedure template This draft template was developed
KU Leuven has received allegations against one of its researchers regarding possible infringements of scientific integrity. The Commission on Scientific Integrity (CWI) at KU Leuven is looking into the matter. According to a report in De Tijd (paywall), university rector Luc Sels is to call together the Committee on Scientific Integrity following a number of complaints against
This article has a number of surprises and new insights. A Tampa-based regenerative clinic accused of using aggressive and unfair marketing tactics to lure the diseased and desperate into spending thousands of dollars on unproven stem cell therapies laid off a “small number of non-medical” employees earlier this week, a company spokesperson confirmed. While it’s
Daylong symposium at MIT showcases innovative ways of sharing facts and building trust in research results. Source MIT News The amount of trust people place in different professions has ebbed and flowed over the years, though in recent years faith in most categories has plummeted, with Congress and the press among the least-trusted groups, surveys
Offshore tests by a startup seek to lengthen people’s telomeres—and their lives. Source MIT Technology Review It’s said that nothing is certain except death and taxes. But doubt has been cast over the former since the 1970s, when scientists picked at the seams of one of the fundamental mysteries of biology: the molecular reasons we
The US Food and Drug Administration (FDA) late last month sent an untitled letter, its third of the year, to California-based Chara Biologics for marketing an unapproved stem cell product as a possible treatment for autism and other conditions with few treatment options. FDA says the product appears to be a human cell, tissue, or
Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John
Fake news works at a cognitive level to shape our perceptions and drive our decisions Fake news grabs our attention, produces false memories and appeals to our emotions “Fake news” is a relatively new term, yet it’s now seen as one of the greatest threats to democracy and free debate. In the Netflix documentary The Great
