Sue Darcey
Senior reporter
Washington DC, USA
15+ years of experience
A Washington DC-based trade journalist with over 30 years' experience covering Capitol Hill and regulatory agencies including FDA, CMS and the EPA, Sue is constantly on the look-out for any new laws, regulations, challenging device and test makers, and ways that firms resolve those issues. She also writes extensively about CMS changes to paying providers for their value-based practices, rather than on a fee-for-service basis, and how the changes affect device reimbursements.
When Sue is not covering the US Congress, CMS, and the medtech industry, she likes to be outdoors, where she can be found birding, hiking, gardening, swimming, and taking photos of flora and fauna of the US mid-Atlantic region.
Medtech Insight: 世界の医療機器・医療技術の最新情報
29 Nov 2020
Health policy changes that President-elect Joe Biden will likely make during his four-year term include Medicaid expansion and a greater reliance on medical science, among others, experts say.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Sue Darcey 27 Nov 2020
The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.
Topic drug-approval clinical-trials Coronavirus policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Sue Darcey 12 Mar 2020
An $8.3bn “Coronavirus Preparedness and Response Supplemental” funding act approved by the US Congress last week and signed into law on 6 March provides dollars and lays out the roles federal agencies, such as the FDA, and state and local agencies must play in containing and controlling the spread of COVID-19.
Topic Coronavirus
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Nov 2019
US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.
Topic fda policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
25 Sep 2018
A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.
Topic drug-review
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世界の薬事規制動向&情報を配信
08 Jan 2016
世界の薬事規制動向&情報を配信
21 Sep 2015