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The Latest Breaking News from Marty Makary

‘The FDA is a complete mess’: Trump makes fate of agency chief unclear as public trust plummets

Food and Drug Administration commissioner’s decisions have hurt staff morale and put his job in crosshairs

The Guardian - US

FDA's new playbook: Lots of media announcements but not much rulemaking

Health Secretary Robert F. Kennedy Jr. and other health officials have repeatedly announced major changes before any new rules have been drafted

The Independent UK

After the FDA spent years rejecting over flavored vape products, Trump reportedly pressed his FDA chief to allow mango and blueberry flavors

“Flavors induce people, many of them children and young adults, to use a product that may result in a lifetime of addiction and other harms,” one anti-smoking advocate said.

Fortune

From analysis to the latest developments in health,
read the most diverse news in one place.

Flavored vapes get FDA approval in major shift under Trump

IN FULL

The Independent UK

FDA approves four flavored vapes days after pressure campaign from Trump

Some health experts have warned that flavored vapes can contribute to underage use

The Independent UK

Trump Pressured FDA to Greenlight Candy-Flavoured Vapes Amid Polls Showing Just 24% Approval With Gen Z

The Trump administration pressured the FDA to approve fruit-flavored e-cigarettes as Trump's support among young Americans declined, raising concerns about political influence on regulatory decisions.

International Business Times UK

FDA blocked studies finding Covid and shingles vaccines safe, HHS official says

Serious side-effects from vaccines were rare, scientists found in studies funded by US taxpayer money

The Guardian - US

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The Promise and Limits of Trump's Psychedelic Therapy Order

The president's facilitation of research and FDA review could help make psychedelics available to approved patients. But what about everyone else?

Reason

RFK Jr. faces barrage from Democrats in House hearings

Kennedy doubled down on some of his most controversial moves, but also gave some ground on measles.

Axios

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

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

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Fortune

'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.

The Independent UK

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

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

Reason

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.

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The Independent UK

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

Reason

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.

The Independent UK

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

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

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