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Pink Sheet

Biden's COVID-19 Advisory Board Bodes Well For Science-Driven FDA

Biden Kamala Covid19 advisory board

Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.

Topic US Election 2020 Coronavirus FDA

Pink Sheet

What Did US FDA Do Wrong In Its Review Of Aducanumab AdCom Members Have A List

FDA Advisory Committee

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

Topic advisory committees Drug Review FDA

Pink Sheet

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

Covid19 HELP Hearing

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

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

Autism Study Digital Health

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

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

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

Medtech Coronavirus test tubes

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

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

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

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

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

fda-sign

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

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