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
January 15, 2019 Gottlieb and his colleagues have spent the past few weeks juggling their resources to cope with the furloughing of around two-fifths (2/5) of the FDA’s staff and loss of the ability to receive new user fees. Most recently, senior leaders at the FDA have worked with public health experts to identify additional … Read more
January 11, 2019 The marketing authorization is the second for Brainsway’s deep transcranial magnetic stimulation (TMS) device in the U.S., after being cleared for treatment-resistant major depressive disorder in 2013. The Jerusalem-based company intends to begin installing the OCD treatment in clinics immediately, as an upgrade to its current systems as well as through new … Read more
January 08, 2019 Each of those officials from the old China FDA (CFDA), recently revamped as the State Drug Administration, has been handed different penalties, according to the state-run China Central Television (in Chinese). The crackdown stems from an investigation of Changchun Changsheng Life Sciences, which recently turned up evidence that it had sold nearly … Read more
January 03, 2019 While TV ads still rule with a 65% recall among patients who saw any prescription drug ads in the past year, digital is rising with 49% remembering online ads, according to DRG Digital/Manhattan Research’s annual Cybercitizen Health study in the U.S. Another 25% of patients reported seeing ads in print, 14% remembered … Read more