Cancer Moonshot Launches in 2017

Cancer Moonshot Launches in 2017

Rare bipartisanship at the end of the Obama administration led to the passage of the 21st Century Cures Act championed by former Vice President Biden. The Act’s leading provision authorized $1.8 billion over 7 years for National Institutes of Health (NIH)-administered research into cancer. Also relevant to cancer therapeutics and diagnostics market development were the Act’s provisions for easing requirements and accelerating review of FDA submissions.


User Fees a Test of New Administration for Device Companies

User Fees a Test of New Administration for Device Companies

One test of the new admin’s stance towards the device industry will be the Medical Device User Fee agreement fee negotiations. It cost over $200,000 for a standard business to launch a new device with the FDA and $4,700 for a “shortcut” or 510 (k) application off a previously approved device. A further reduction or limited/no increase are goals of the industry.


Uncertain Consequences for U.S. Health Care Post-Election

Uncertain Consequences for U.S. Health Care Post-Election

Incoming Republican congressional majorities and an administration of president-elect Trump have injected plenty of uncertainty into the U.S. healthcare system. Dismantling the Affordable Care Act (ACA) will be a legislative priority of the new regime, but could take years to accomplish. Which ACA provisions are kept and how coverage is preserved for newly insured individuals are currently open questions.


Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Cancer is the common thread through several fronts of U.S. regulatory development, whether approval of targeted therapeutics; coverage and reimbursement decisions for advanced diagnostic laboratory tests (ADLTs); or expansion of FDA regulatory oversight over laboratory developed tests (LDTs). The disease is also a healthcare and research and development (R&D) focus of the Obama administration. Just as instrumental as cancer’s high societal burden and aging-driven rise in incidence, the proliferation of its genetic analytes and druggable targets has caught the attention of regulators.


Ebola Diagnosis on the Fast Track

Ebola Diagnosis on the Fast Track

In addition to expedited device approvals for diseases without effective existing treatments, the FDA has also fast-tracked Ebola tests under its emergency responsibilities in the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The FDA’s announcement of emergency use authorizations (EUAs) for Ebola test kits beginning in August 2014 promoted the development of several tests by both public organizations and private industry. Test development has been along the lines of rapid d...