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Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

FDA_Stands_Ready_To_Fight_Coronavirus

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

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Topic Approvals Compliance Regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Topic drug-approval clinical-trials Coronavirus policy-and-regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Act Quickly On Converted EU Product Approvals GB Firms Urged

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year. 

Topic Pharma-Brexit brexit drug-approval

Medtech Insight: 世界の医療機器・医療技術の最新情報

QUOTED. 24 January 2020. Megan McSeveney.

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Drug approval Coronovirus FDA

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Podcast: Significant Approvals, Diabetes and NASH In India, Japan M&A

Join the Asia-based content team for Scrip and the Pink Sheet for their first podcast as they take a look at some of the most significant regional pharma stories of the past few weeks.

Topic drug-approval business-strategies

ターゲット市場の実像をつかむ

Understand Market Access Trends in the US, Europe and Emerging Markets

Understand Market Access Trends in the US, Europe and Emerging Markets

This essential whitepaper looks at how increased drug spending and a rising desire for expenditure controls are influencing access dynamics across key markets. It is available to you now, for free.

Topic Drug Development Landscape Approvals Drug Review

Datamonitor Healthcare: 医療用医薬品の市場調査レポート

オンラインセミナー:NASH治療薬の展望と市場動向

オンラインセミナー:NASH治療薬の展望と市場動向

NASH(非アルコール性脂肪性肝炎)はさらに大きな流行病となりつつあり、あらゆる規模の企業が、業界初のNASH治療薬を市場に出すためにしのぎを削っています。新薬および転用された新薬探索、NASHの治療に関する詳細なディスカッション、およびこの分野のディールメイキング、ライセンスシング、提携戦略についてお聞きください。

Topic cell-and-gene-therapy drug-development-landscape drug-approval

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オンラインショップのレポートストアでは、医療用医薬品の市場調査・分析レポートを常時1000本以上販売しています。レポート1本単位で購入でき、オンラインでご提供いたします。

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