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The Latest Breaking News from Marty Makary

Trump and RFK Jr touted leucovorin as a treatment for autism. The FDA quietly walked it back

Outpatient prescriptions for the drug increased 71% after news, but FDA later approved it only for folate deficiency

The Guardian - US

FDA Officials Say Autism Claims for Drug Promoted by Donald Trump Lack Strong Evidence

FDA officials say there is no strong evidence that leucovorin helps most people with autism despite earlier claims promoted by Donald Trump.

International Business Times

What is leucovorin? FDA expands drug’s approved use but walks back autism claims

Unresolved questions about the drug haven’t stopped U.S. doctors from prescribing it

The Independent UK

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FDA finds little evidence that a generic drug could help many people with autism

The FDA is approving a generic drug for a very rare genetic disorder, but not for autism

The Independent UK

Trump administration’s embattled FDA vaccine chief departing for the second time

Vinay Prasad to leave in April after decisions involving vaccine reviews and specialty drugs for rare diseases

The Guardian - US

'Usually everybody loves money': Trump's FDA chief to start giving bonuses for faster drug reviews

The FDA lost about 20% of its workforce after Trump took office last year. Now it wants to shrink approvals from as long as 29 months to as low as six.

Fortune

FDA to offer bonus payments to staffers who complete speedy drug reviews

The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete their work ahead of the schedule

The Independent UK

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FDA proposes new system for approving customized drugs and therapies for rare diseases

The Food and Drug Administration is proposing a system for approving customized drugs and medical treatments for patients with rare or hard-to-treat diseases

The Independent UK

FDA Commissioner Says 'Everything Should Be Over the Counter.' Don't Count on Big Pharma To Lead the Way.

A system that allows drug makers to profit from restricted access will never liberalize on its own—and patients will continue to bear the cost.

Reason

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

Companies can now claim 'no artificial colors' if they add plant-based color to food

The U.S. Food and Drug Administration is relaxing rules that restrict when food companies can claim their products have no artificial colors

The Independent UK

How To Speed Up the Search for Cures Through a Change in Probability Theory

It seems likely the FDA would do well to accept more Bayesian reasoning in medical research.

Reason

The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers

AI-powered medical wearables and software are flourishing following the FDA’s new regulatory guidance.

Reason

Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times

The Independent UK

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Roll Call

Top-down approach has Congress AWOL on FDA, experts say - Roll Call

Since President Donald Trump took office, the FDA has lost about 20 percent of its staff through reduction-in-force efforts.

The Guardian - US

‘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

Marie Claire

After Nearly Three Decades, the US Might Finally Be Getting a New Sunscreen Filter

SPF in America might finally catch up to Europe, Asia, and Australia.

Axios

FDA reaches "tipping point" after high-level departures

Biotech and pharmaceutical companies rely on the FDA for guidance as they spend huge sums developing treatments.

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Benzinga

Anthony Fauci Under Fresh Fire As FDA Chief Makary Argues COVID-19 Lab Leak Theory Was 'Massive Cover-Up:' 'It's A No Brainer...'

The U.S. Food and Drug Administration’s (FDA) top official ignited fresh debate on Wednesday by accusing Dr Anthony Fauci on the “Pod Force One” podcast of suppressing early scrutiny of COVID-19’s origins, calling the alleged effort a “massive cover-up” during the first months of the pandemic.

The Guardian - US

Doctors respond to ‘data-free’ decision over menopause hormone therapy: ‘It’s not true’

Physicians say FDA panel conflated two issues and made baseless claims about unproven health benefits

Benzinga

FDA Names Veteran Oncologist Richard Pazdur To Lead Drug Center After Ethics Scandal Ousts George Tidmarsh

The U.S. Food and Drug Administration (FDA) has appointed Dr. Richard Pazdur as the new head of its drug center, succeeding Dr. George Tidmarsh, who was removed following an ethics complaint just months after his appointment.

International Business Times UK

Black Box Warning Facts: Why is the FDA Removing the Warning Label from Hormone Therapy Drugs

The FDA has removed black box warnings from menopause hormone therapy drugs, marking a major milestone for women's health after decades of fear over outdated risks.

Roll Call

FDA removes warning for hormone replacement therapy for menopause - Roll Call

The Food and Drug Administration is removing "black box" warnings on hormone replacement therapy for menopause.

The Independent UK

FDA will remove long-standing warning from hormone-based menopause drugs, citing benefits for women

The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause symptoms in women

Benzinga

FDA Drug Chief George Tidmarsh Resigns After Allegations Of Power Misuse

George Tidmarsh, head of the Food and Drug Administration’s (FDA) drug center, resigned Sunday following allegations that he misused his regulatory power to financially harm a former business associate.

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