June 19, 2018 Medical representatives are defined as professionals, rather than sales persons, who perform academic promotion and technical consultancy work, so it is “not surprising that the CFDA requires medical representatives to have certain qualifications and/or related experience,” Katherine Wang, Partner at law firm Ropes & Gray in Shanghai, tells FDAnews. Under current CFDA … Read more
June 14, 2018 Since those comments in January 2017, the United States Food and Drug Administration (FDA) has withdrawn the most rulemakings of any Department of Health and Human Services (HHS) Agency, though only a handful are related to medical products (the others are tobacco related) and it is unclear how the withdrawal of these … Read more
June 12, 2018 Traditionally, patients who receive cochlear devices to help their hearing must repeatedly return to the clinic after implantation. At these visits, audiologists adjust the settings of the implant to alter how the patient perceives sounds. The aim is to improve the patient’s ability to understand speech and cope with loud environments by … Read more
June 07, 2018 This method, however, is not necessarily the most accurate way of gauging the severity of a concussion, and better markers have been sought. In November 2017, writing in JAMA Pediatrics journal, researchers from Penn State College of Medicine have found a new marker in an unusual place: a patient’s spit. Specifically, the … Read more
June 05, 2018 Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name drugs and generic drugs with no competition. FDA Commissioner Scott Gottlieb praised the bill’s passage … Read more
May 31, 2018 The two-year-old DDF — which is run by venture capital firm SV Health and backed by several big biopharma companies and medical charity Alzheimer’s Research U.K. — is focused on backing groups that discover and develop disease-modifying drugs for Alzheimer’s, which despite decades of research can still only be treated with a … Read more
May 29, 2018 Now, they have found a way to manipulate autophagy to lower the risk of Zika infection in developing fetuses, using one of the world’s best-known drugs: the malaria treatment hydroxychloroquine. The research team discovered that hydroxychloroquine, which is listed as an essential medicine by the World Health Organization (WHO), blocks the transmission … Read more
May 24, 2018 Specifically, the devices will be used at the Scripps Translational Science Institute (STSI), which runs The Participant Center, which aims to enroll diverse populations across the U.S. in the program. STSI will provide Fitbit devices to a representative sample of All of Us volunteers for use in a one-year study, according to a … Read more
May 22, 2018 The MDSAP consortium announced Oct. 31, 2017 it has tweaked the program, in response to comments received from Canadian medical device license holders, by the actions as follows: reducing the total number of tasks; introducing reduction in audit time for manufacturers; reducing the duration of surveillance and re-certification audits; and clarifying the … Read more
May 17, 2018 FDA Commissioner Scott Gottlieb, M.D., is proposing to grant these freedoms to companies that complete a one-time review. In shifting regulatory attention from individual products and onto the companies that make them, the FDA is following the playbook it created for digital health. Both of the approaches loosen regulatory oversight of pre-certified … Read more