February 19, 2019 The session at a conference jointly hosted by the American University Washington College of Law and the Food and Drug Law Institute in October featured former FDA commissioners Robert Califf, Margaret Hamburg, David Kessler and Andrew von Eschenbach. Lewis Grossman, Professor of Law at the American University, questioned the former commissioners on … Read more
February 15, 2019 Her interest was initially piqued by a Harvard study that found older patients who had female doctors had better outcomes than those with male doctors. That got Dorfman thinking about what, if anything, that might mean for CMI/Compas clients who want to contact, converse with and educate physicians about their products. The upshot: Should pharma companies … Read more
February 12, 2019 Rather than using human neurons, the Tufts team used human-induced pluripotent stem cells (iPSCs) to build their models. The resulting models carried the key structural and functional features of the brain and maintained neural activity for at least nine months, the team reported in the journal ACS Biometerials Science & Engineering. Because … Read more
February 07, 2019 Much speculation has surrounded when and how the tech giant would jump into the healthcare waters — and it did so with a large splash, unveiling the new Series 4 model and its federal de novo clearance at Apple’s iPhone launch event in Cupertino, California. Additionally, through new accelerometer and gyroscope hardware, … Read more
February 06, 2019 The Health and Human Service (HHS) Inspector General’s Office recommended the FDA and manufacturers use pre-submission meetings to better address cybersecurity-related questions, and that the agency include cybersecurity as an element in its SMART template used in 510(k) submissions. In addition, the Office urged the agency to begin requiring cybersecurity documentation elements … Read more
January 31, 2019 The EMA is set to leave its offices in London 01 MAR 2019 and start gradually moving staff into its temporary home in Amsterdam about 10 days later. In the intervening week, the EMA will “operate on the basis of extended teleworking,” with only a small number of staff occupying its Amsterdam … Read more
January 29, 2019 In signing a temporary funding bill late last week, Trump has enabled furloughed FDA staff to return to work today. FDA Commissioner Scott Gottlieb said he is working to get back pay to staff by the end of the month and is otherwise taking actions to ensure they and the agency can … Read more
January 24, 2019 In a report to the drug and device producers in August 2018, Secretary of State for Health and Social Care, Matt Hancock, said they needed to report by Sept. 10, 2018 how they will stockpile in the U.K. those medications currently made in Europe but sold to the National Health Service. It … Read more
January 22, 2019 Managers at Juxin Biotech in Lianyungang, Jiangsu, including its Safety Director, Wang Ruren, will be criminally prosecuted after an explosion in December 2017 killed 10 and injured another, according to a report from the Ministry of Emergency Management. The biotech also will be fined 5 million yuan (US $730,750), and its production … Read more
January 19, 2019 The first is a hormone called leptin, which is known to help control our desire to eat. It is released from white fat tissue and it acts on neural receptors in the brain’s hypothalamus to stimulate the feeling of a full stomach. In people who are obese, leptin is still present in large … Read more