EMA staff lowers flags at London office as Amsterdam move nears

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

FDA staff returns to work, but threat of second shutdown looms

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

China prosecuting managers of Juxin Biotech after plant explosion kills 10

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

2 proteins show promise as targets for treating obesity

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

FDA starts more unpaid work as shutdown enters week 4

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

FDA clears firs magnetic, noninvasive device treatment for OCD

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

Former China FDA Chief to resign over the country’s latest vaccine scandal

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

‘Ask your doctor’ pitches from digital ads work almost as well as ones on TV

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

FDA Medical Device User Fee Rates for Fiscal Year 2018

The below letter was directed to Medical Device Establishments in August 2017 to address FDA Medical Device User Fee Rates for Fiscal Year 2018 as follows: This letter provides information regarding medical device user fees, including fee rates and payment procedures, for fiscal year 2018 (FY18), which runs from October 1, 2017 through September 30, … Read more