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Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance

Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.

Topic Coronavirus vaccines fda

Medtech Insight: 世界の医療機器・医療技術の最新情報

Cognoa Seeks De Novo Clearance For AI-Powered Diagnostic App For Autism After Successful Study

FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers.

Topic Diagnostics digital-health fda

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

What Justice Ginsburg's Death Means For Pharma

Supreme Court Washington

A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.

Topic US Election 2020 FDA

Medtech Insight: 世界の医療機器・医療技術の最新情報

COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight

US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.

Topic Coronavirus fda

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Plasma Authorization Raises Fears Of Politically-Influenced COVID19 Vaccine Decisions, Compromised FDA

Politically influenced Covid19 vaccines

US FDA Commissioner Hahn’s credibility is in question following an emergency use authorization for convalescent plasma, leading some former officials to push for new agency leadership. Hahn’s actions, combined with President Trump’s attack on FDA staff as being ‘deep state’ actors, may compromise the public trust in the agency’s work during COVID-19 and beyond, former FDA officials say.

Topic Coronavirus FDA

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Boosts Development Of OTC COVID-19 Tests With New Template

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Topic Coronavirus FDA Diagnostics

Medtech Insight: 世界の医療機器・医療技術の最新情報

COVID-19 Antibody Tests Being Abused To Falsely Diagnose Coronavirus Cases, FDA Says

A negative COVID-19 antibody or serology test, even when authorized by FDA, is a poor indicator of whether an individual currently has or is completely immune from contracting coronavirus, the agency said on 4 May, issuing an updated guidance to drive the lesson home.

Topic Coronavirus Policy & Regulation FDA

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic

FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic

FDA guidance updated in mid-April offered workarounds for trial sponsors attempting to conduct clinical studies in a time of travel limitations, staffing changes and heightened patient safety issues. For trials involving complex products and administration, such as cell and gene therapies, sponsors must determine whether modified protocols can still maintain trial integrity. If not, it may be time to press pause. 

Topic Coronavirus FDA

Pharmaprojects: 医薬品開発パイプラインのデータベース, Biomedtra...

The Race to Find a COVID-19 Treatment - Infographic

The Race to Find a COVID-19 Treatment - Infographic

Access this infographic which focuses on Gilead’s drug Remdesivir which currently shows the greatest promise for the likelihood of approval as a possible treatment to effectively treat the virus. The infographic highlights the drug summary and profile, the number of patients in each trial phase, and the history of events that have moved this product through the development process.

Topic Coronavirus FDA Drug Review

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