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
November 05, 2018 The Agency intends to focus more of its policies on supporting developers that pursue safer devices, he said. As part of its new Medical Device Safety Action Plan the agency raised the possibility of providing an approval path for safer devices that don’t meet its Breakthrough Program criteria but are intended to … Read more
November 01, 2018 CDRH staff have tried to apply a total product lifecycle (TPLC) approach to regulatory decision-making, however, a major barrier has been the existing silos of functions, on the pre- and post-market side within the center’s offices, CDRH Director Jeffrey Shuren said at the 2018 FDA/Xavier Medcon conference in Cincinnati in May. By … Read more
October 30, 2018 To capitalize both on that growth and its available resources, the Government of Australia began offering tax incentives to attract more global drug developers to the country to conduct early stage clinical trials, as well as build on the research excellence and drug development infrastructure in the country. “From a regulatory aspect, … Read more
October 25, 2018 Dubbed “Pre Cert 1.0,” the program will be the first formal iteration of a pilot project launched with nine companies last September. The Agency plans to build the program using a working model and an updated roadmap, released in April, that evaluates each manufacturer’s transparency, culture of quality and organizational excellence rather … Read more
October 23, 2018 Almost three-quarters (3/4) of U.S. offices are designed with an open desk plan. Microsoft Corp. has one; so does Etsy Inc.; even the General Services Administration (GSA), the government’s landlord, is pitching a wall-free model to federal agencies. Employers love open plans because they save money — you can cram a lot … Read more
October 19, 2018 The 17-page document is split up into five sections that address the aforementioned topics plus the creation of a patient safety net, integration of pre and postmarket oversight and steps the FDA could take to intervene faster when safety threats arise. Collectively, the proposals are intended to ensure technological advances translate into … Read more