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The Latest Breaking News from Robert Califf

FDA revamping foods program to move past ‘constant turmoil’

The head of the Food and Drug Administration has announced an overhaul of the agency's food safety and nutrition division

The Independent UK

FDA food safety official resigns, cites structural issues

The Food and Drug Administration's top food safety official has resigned

The Independent UK

Panel warns FDA’s beleaguered tobacco unit lacks direction

A new report criticizes the Food and Drug Administration’s efforts to oversee the tobacco industry, including traditional cigarettes and vaping products

The Independent UK

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Panel calls for stronger leadership of FDA food programs

A panel is calling for changes at the federal agency that oversees most of the nation's food supply, saying revamped leadership, a clear mission and more urgency are needed to prevent illness outbreaks and to promote good health

The Independent UK

FDA panel backs removal of unproven pregnancy drug

A panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work

The Independent UK

FDA chief touches on many issues during Lexington visit

The head of the Food and Drug Administration says more needs to be done in the area of treatment for pain. FDA Commissioner Robert Califf came to Lexington to participate in University of Kentucky Healthcare’s 60 Anniversary Symposium

WEKU

FDA concedes delays in response to baby formula shortage

U.S. health regulators say their response to the ongoing infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory

The Independent UK

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Bipartisan Lawmakers Call Out FDA's 'Inadequate' Response To Hemp And CBD Regulations

Bipartisan House members sent a letter to the FDA commissioner to complain about the agency's “completely insufficient response” to their bill, which called for hemp-derived CBD to be permitted and regulated as a food additive.

Benzinga

FDA greenlights new COVID-19 booster despite limited data - Roll Call

The Food and Drug Administration granted emergency authorization to Pfizer and Moderna for updated COVID-19 booster shots.

Roll Call

FDA chief says long-awaited opioid review still in the works

The head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway

The Independent UK

Omicron booster shots are right around the corner

They're expected to become available right after Labor Day.

Axios

This drug could help treat monkeypox. Some patients have struggled to get it

Joseph Cassara decided to head back to the emergency room when the pain made it unbearable to swallow.

Los Angeles Times

White House announces steps to boost monkeypox vaccine supply

The FDA has issued emergency authorisation for a dosage technique that would allow more shots of vaccine per vial.

Al Jazeera

FDA considering "dose-sparing" approach to increase availability of Jynneos vaccine

Health care providers could use one vial of the vaccine to administer up to five doses without an impact on safety or efficacy.

Axios

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Axios

The next public health emergency

Facing a groundswell of criticism for its sluggish response to monkeypox, the Biden administration declared a public health emergency on Thursday, potentially unlocking millions of dollars toward increasing vaccine availability in the U.S.

Roll Call

Administration declares monkeypox a public health emergency - Roll Call

The administration declares monkeypox a public health emergency and says it will make it easier to get vaccines to patients.

Reason

Not Even the FDA Trusts the FDA To Regulate Food Safety

The FDA has effectively thrown up its hands over its most important food-related role.

The Independent UK

FDA chief's long-promised opioid review faces skepticism

The head of the Food and Drug Administration says a comprehensive review of the opioid painkillers that triggered the nation's ongoing overdose epidemic is in the works

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WEKU

5 things to know about the FDA's flawed approach to accelerated drug approvals

An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.

WEKU

Drugmakers are slow to prove medicines that got a fast track to market really work

Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.

The Independent UK

FDA weighs oversight changes after Juul, formula troubles

The head of the Food and Drug Administration is commissioning an independent review of the agency’s food and tobacco programs

WEKU

The FDA authorizes COVID-19 shots for infants and preschoolers

The vaccinations for children as young as 6 months old could start next week. But first, the Centers for Disease Control and Prevention must sign off.

The Independent UK

Baby formula shortage will stretch on until late July, FDA chief says

‘My expectation is that within two months we should be beyond normal and with a plethora’

Reason

The FDA Completely Botched Its Response to the Baby Formula Shortage

Plus: Resurrecting an extinct tiger, reviewing the police response to the Uvalde shooting, and more...

Los Angeles Times

FDA acknowledges slow response, 'suboptimal' decisions leading up to infant formula shortage

WASHINGTON — Sluggish response and questionable decisions by the Food and Drug Administration exacerbated the nation's infant formula shortage, agency officials told lawmakers at a congressional hearing on Wednesday.

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