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
October 16, 2018 Probably not, said several industry experts interviewed by FiercePharma, although Pharmas should still keep an eye on the controversy. Cambridge Analytica’s mishandling of data collected in apps spurred Congress to hold hearings with Facebook CEO Mark Zuckerberg in the first part of April 2018. That app-oriented issue does not apply to pharma … Read more
October 11, 2018 SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an Institutional Review Board (IRB). According to four people with knowledge about … Read more
October 09, 2018 Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause … Read more