July 13, 2018 A Kaiser Health News (KHN) analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services. Azar was confirmed in January as HHS Secretary, joining other former drug industry alumni in top positions. Nearly … Read more
July 10, 2018 The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) in January posted joint Warning Letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. “The FDA is … Read more
July 06, 2018 Republicans’ failure to overturn Obamacare or include measures to repeal the 2.3% medical device levy in broader tax legislation meant the previously delayed charge came into force at the start of the year, despite intense industry lobbying and opposition to the tariff among both political parties. Now, with the day on which … Read more
July 03, 2018 John Maraganore, CEO of Alnylam, who has a biotech CV as long as your arm, had this to say about reports that Trump asked at a White House meeting why he should accept immigrants from “shithole countries” rather than from places like Norway: “My Mom and Dad came to this country from … Read more
June 28, 2018 People inside and outside the FDA have long discussed the publication of the CRLs the Agency sends to companies to notify them it is rejecting their applications for approval. Such transparency would enable everyone to know why the FDA rejected an application. Today, researchers, investors and other interested parties rely on the … Read more
June 26, 2018 State senators have filed the “Drug Take Back Act,” which instead of being aimed directly at drug-makers, would require chain and mail-order pharmacies to establish federally approved disposal systems for consumers, the New York Daily News reports. Those might include on-site disposal or prepaid mail-back envelopes. Republican State Sen. Kemp Hannon, one … Read more
June 21, 2018 The U.S. Food and Drug Administration (FDA) and the Department of Defense’s (DoD) Office of Health Affairs announced in January the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel. “The FDA is fully committed to … Read more
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