Telehealth and telemedicine have been slow to catch on for a number of reasons, but the U.S. Federal Communications Commission (FCC) has proposed a pilot program to increase the use of telemedicine for low-income Americans and military veterans. While access to broadband services is still an issue for many, the so-called Connected Care Pilot drew support from a range of stakeholders, who argued that telehealth is critical to managing public health crises, such as diabetes and the opioid epidemic.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

The FDA's September 2018 draft guidance for considerations of benefit-risk determinations for several device types, including PMAs, said that the agency "intends" to hold an advisory committee hearing if the FDA has any questions about the post-market data generated by the accompanying post-approval study. The final guidance pulls back on that language, but only slightly, stating that the agency "generally expects" to hold an advisory hearing in this circumstance, a difference in language that may or may not translate to a difference in function.

SEOUL – South Korea's investors have become very interested in the global cell and gene therapy market. Licensing and M&A deals in the field have been active – a good sign for Korean biopharma firms eager to tap in.

SAO PAULO, Brazil – Latin America is following the lead of other developed markets by ramping up its focus on personalized medicine, but there are challenges, including the higher costs of those medicines and a lack of regulations.

There have been studies comparing approval rates of the FDA and the EMA, but an analysis of the scientific basis behind those decisions is difficult.