December 11, 2018 The Agency approved Epidiolex, or purified cannabidiol, to treat Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older. The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex … Read more
December 06, 2018 “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said in November. … Read more
December 04, 2018 The series of stories published in November 2018 across several outlets details the patchwork of international regulatory regimes overseeing the medical device industry, finding products being marketed with little to no human testing, or devices pulled from sale due to safety concerns in some countries while still being sold in others. For … Read more
November 29, 2018 The current dual role makes no sense, according to a White House document that wants around 5,000 FDA staffers transferred to the U.S. Department of Agriculture so that all food regulation occurs under one roof. The current structure at the FDA is a relic of the early 1900s that “introduces greater risk, … Read more
November 27, 2018 Details of Gates MRI first emerged more than 12 months ago; however, at that point the project was yet to move past the operational design phase. Now, the R&D operation has temporary digs in Cambridge, Massachusetts, and a leadership team lured from companies including Baxalta, Merck and Shire by the promise of … Read more
November 25, 2018 The CARB-X project — which announced the new funding at the World Health Assembly meeting in Geneva in May — was set up two (2) years ago as a public-private partnership to provide funding for new projects that address the global rise of antibiotic-resistant bacteria, particularly in low- and middle-income countries. It’s … Read more
November 20, 2018 Instead, the Agency found that many OEMs and third parties provided high-quality, safe and effective servicing, such as refurbishing and reselling more durable equipment including imaging machines, automated external defibrillators, endoscopes and ventilators. “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread … Read more
November 15, 2018 In May, Department of Health and Human Services (DHHS) Secretary Alex Azar called on pharma companies to voluntarily add drug prices to ads. “Be honest about what you’re trying to charge us, and put your list prices in your ads,” Azar said during a speech outlining details about the bigger plan, the … Read more
November 13, 2018 Each additional meal purchased was associated with an increase of 0.7% in opioid claims by doctors, according to the research published in JAMA. Meals were the perk most frequently accepted by doctors — more than 97,000 physicians let pharma pick up the tab for breakfasts, lunches or dinners for a total of $1.81 … Read more
November 08, 2018 Developers of therapies that feature device and drug or biologic components can ask the FDA to classify their products. These classifications are based on the primary mechanism of action and determine how the regulator handles combination products. That process looks set to survive the first major review of the regulations since 1991. … Read more