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
October 04, 2018 The action could have negative consequences for medical device manufacturers and the patients who use their products. Chinese-made products account for a significant minority of devices imported into the U.S. Some of the imported devices come from Chinese companies. Others are manufactured by Western companies with operations in China. Estimates of the … Read more
October 02, 2018 Woonsocket, Rhode Island-based CVS established itself as a national brand through its pharmacies; however, over the past decade or so it has broadened its scope, notably by merging with pharmacy benefit manager (PBM) Caremark Rx and striking a deal to buy insurer Aetna. Now, CVS is moving onto turf traditionally colonized by … Read more
September 27, 2018 The Regulatory Agency (CDSCO) told the Economic Times it is in the process of finalizing the software to be used for the database and will amend its rules and regulations to make it mandatory for manufacturers to regularly put details of their facilities and products into the database. India does not have … Read more
September 25, 2018 The package (Chinese) would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies. The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of … Read more