US FDA Rolls out New Market Pathway for Breakthrough Medical Devices
October 26, 2017
By Neozene

The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program. Mandated by the 21st Century Cures Act, the Breakthrough Devices Program will incorporate elements from the EAP, Innovation Pathway and Priority Review Program to expedite development and regulatory review of cutting-edge devices targeting serious diseases and conditions. The FDA draft guidance explains how the agency plans to implement the Breakthrough Devices Program, as

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Despite notable failures, cancer vaccines are poised for a leap onto the market
October 19, 2017
By Neozene

It’s no secret that cancer vaccines have turned in multiple late-stage failures, putting a serious damper on enthusiasm in the field. But one oncology expert believes we’ll see licensed cancer vaccines in the next two to three years in immuno-oncology combo treatments. Dr. Gerry Messerschmidt, chief medical officer of cancer-focused CRO Precision Oncology, says scientists need to solve several problems inherent to cancer vaccine development. For instance, cancers continuously grow in the body, and they wreak havoc on the immune system. One way to overcome those challenges is by slotting

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Medical Device Cybersecurity Legislation Advances in US Congress
October 17, 2017
By Neozene

New US legislation that would establish a working group led by the Food and Drug Administration to improve cybersecurity measures in medical technology has been introduced in the House of Representatives. The Internet of Medical Things Resilience Partnership Act would task the FDA and other government, academic and industry organizations with developing recommendations and guidelines for boosting cybersecurity and resilience of networked medical devices within 18 months of passage of the Act by the full Congress. The bill appears to take into account recommendations recently published by the Health Care

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