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The Latest Breaking News from Vinay Prasad

FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals

The Independent UK

FDA refuses to consider Moderna flu shot in move experts claim is part of ‘anti-vaccine agenda’

Experts say ‘they’re just coming up with reasons’ as agency says application lacked ‘adequate and well controlled’ trial

The Guardian - US

FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine.

The Conversation

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FDA declines to review Moderna application for new flu vaccine

Moderna requests meeting to discuss refusal as decision could have implications for all new and updated vaccines

The Guardian - US

FDA declines to review Moderna’s new flu vaccine

This decision signals heightened scrutiny of vaccines by the FDA under Health Secretary Robert F. Kennedy Jr.

The Independent UK

Legal questions swirl around FDA's new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been rocked by recent layoffs and resignations

The Independent UK

‘She has no expertise’: the US medical community girds for Tracy Beth Høeg’s tenure at the FDA

The Danish American who doubted Covid shots is meant to lead drug regulation – but has focused on vaccines

The Guardian - US

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FDA to update regulations after unconfirmed claims of Covid vaccine-linked death

Announcement, and lack of details in the weeks following, represents major departure from previous FDA priorities

The Guardian - US

This RFK Jr.-founded group demands the FDA kill the COVID vaccine

An anti-vaccine organization founded by Robert F. Kennedy Jr. filed a petition to remove the shots from the market.

Axios

‘Never seen anything like this’: alarm at memo from top US vaccine official

Vinay Prasad memo said at least 10 children had died from Covid vaccination – but offered scant evidence for claim

The Guardian - US

FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access

The Food and Drug Administration is seeking to drastically change procedures for testing vaccine safety and approving vaccines, based on unproven claims that mRNA-based COVID-19 vaccines caused the death of at least 10 children.

The Conversation

FDA drug chief signals possible exit as agency turmoil deepens

Richard Pazdur’s potential retirement weeks into the role adds to upheaval at the FDA amid political pressure

The Guardian - US

FDA Vaccine Chief Claims COVID Shots Linked to 'At Least 10' Child Deaths but Offers No Data

US FDA's vaccine director Dr. Vinay Prasad wrote a memo to their staff that claimed multiple child deaths were related to COVID-19 vaccines without data to back it up.

International Business Times UK

FDA's Prasad Cites Alleged Child COVID Shot Deaths in Push for Stricter Rules

The Food and Drug Administration’s top vaccine regulator is pushing new limits on how vaccines win approval. The tougher standards could cloud prospects for vaccine makers and rattle investors in major healthcare and biotech names.

Benzinga

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The Guardian - US

Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’

Lead FDA vaccine regulator announced new approval process after claiming Covid vaccine had killed 10 children

Axios

Top FDA official threatens to crack down on vaccine approvals

The internal memo comes after an internal agency review linked COVID-19 vaccines to the deaths of 10 children.

The Independent UK

FDA to introduce new Covid-19 vaccine protocol after report claims shots killed 10 children

The FDA will also review its guidance for annual flu shots, according to a memo

The Texas Tribune

A small Texas think tank cultivated COVID dissidents. Now they’re running U.S. health policy.

People with ties to Brownstone Institute have significant authority over access to vaccines and scientific research.

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The Guardian - US

Turmoil and tensions at FDA after dramatic exit of top drug regulator

Scramble to find replacement for George Tidmarsh shines light on dysfunction at US regulatory agency

Axios

Chaos at the FDA leaves staffers disturbed, ready to leave

Questions over reliability have risen over the underperforming and dysfunctional FDA.

Benzinga

FDA Outlines Process To Speed Up Rare Disease Therapy Approvals

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations.

Reason

FDA Official Pressures YouTube Into Removing a Channel For Posting His Own Vaccine Comments

Not long ago, conservatives were rightly concerned about jawboning. Now they're apparently happy to take part in it themselves.

The Independent UK

Over 1,000 HHS staffers demand RFK Jr resign as civil war swirls over his remaking of the agency

Employees past and present come togther to express lack of confidence in Robert F Kennedy Jr over turbulent leadership of America’s public health institutions

The Guardian - US

Top FDA official demands removal of YouTube videos in which he criticized Covid vaccines

Channel was an attempt to ‘preserve’ what officials in current Trump administration said during the pandemic

The Independent UK

MAGA firebrand Laura Loomer breaks with Trump in rare public spat over 600k China student visas: ‘Do the math’

Loomer, who has the ear of the president, criticized him after he hailed the ‘very important relationship’ with Beijing

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Marjorie Taylor Greene

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