Medtech Insight: 世界の医療機器・医療技術の最新情報

EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

Topic EU policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

COVID-19 Has Prompted An 18-Fold Increase In German IVDs Production Capacity

How coronavirus affects IVDs businesses depends on the branch of the industry they are in, a German survey of manufacturers shows. German labs performed one million COVID-19 tests last week.

Topic Coronavirus EU policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

Cancer Research UK: Early Diagnosis And Disease Detection Must Not Be Eclipsed By COVID-19

Coronavirus has diverted the focus of health systems away from early cancer detection, says a new report by Cancer Research UK, urging a rebalancing of priorities.

Topic cancer 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

US Election 2020: Trump's Sway Over Courts Expected To Linger

Textualist judges appointed by President Trump during his term may block a potential President Biden’s attempts to shift the government’s legal policies.

Topic us-election-2020 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

'Like Water': Pharma Avoids Much Scrutiny In Messy Presidential Debate

Trump and Biden trade barbs in debate that included a suggestion by the president that coronavirus vaccine development delays are political and saw Biden questioned on whether he was contributing to vaccine hesitancy.

Topic US Election 2020 Drug Pricing Policy & Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

'No Turning Back' On Regulatory Changes at UK MHRA

The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.

Topic policy-and-regulation brexit

Medtech Insight: 世界の医療機器・医療技術の最新情報

Lack Of Joined Up Data Must Be Addressed By Registries In New UK Device Legislation

The Cumberlege Review of patient safety delivered a damning verdict on the UK’s health system. Its recommendations must be acted on, says a consensus of stakeholders.

Topic policy-and-regulation medtech

Generics Bulletin: ジェネリック＆バイオシミラーニュース

EMA Endorses Dexamethasone For COVID-19

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

Topic Coronavirus policy-and-regulation