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The Latest Breaking News from Robert Califf

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

Biden administration officials take bipartisan flak on monkeypox response

Senators on the HELP Committee said the vaccine rollout was too slow.

Politico

US approves shots targeting Omicron

Washington (AFP) - US officials Wednesday authorized updated Covid-19 vaccinations by Moderna and Pfizer-BioNTech that specifically target the latest strains of the Omicron variant, hoping to contain a new wave of feared contagions this winter.

AFP

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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

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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

Monkeypox dose sparing? Biden admin looks to NIH-funded study for clues.

The FDA is considering recommending dose-sparing of the monkeypox vaccine. It is using this 2015 study to back up a potential recommendation.

Politico

Amazon sees opening in baby formula industry shake-up

The online retail and grocery giant reported lobbying numerous parts of the federal government about infant formula as the supply crisis blew up this spring — the first time it's weighed in on the issue.

Politico

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

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.

Axios

Clinton-era FDA commissioner to lead external review of key agency offices

Jane Henney will be spearheading the Reagan-Udall Foundation's evaluation of the FDA's food safety and tobacco divisions.

Politico

US declares monkeypox a public health emergency

Washington (AFP) - US President Joe Biden's government on Thursday declared monkeypox a public health emergency, a move that should free up new funds, assist in data gathering and allow the deployment of additional personnel in the fight against the disease.

AFP

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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.

Politico

Abbott plant shipping out first baby formula produced since recall

The company at the center of ongoing baby formula shortages is also expected to release a new tranche of specialty formula supplies in the coming days.

Politico

‘A movie set’: Former supervisor at baby formula plant says flaws were hidden

An employee account of longstanding problems raises more questions about adequacy of FDA inspections.

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.

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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

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.

Politico

FDA announces external review of food safety and tobacco regulatory offices

The agency has received criticism in recent months over its role in the infant formula shortage and its regulation of electronic cigarettes.

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

Politico

NBC health analyst Vin Gupta passes on Biden admin role

The well-known pulmonologist was under consideration for a top FDA gig but decided against it.

Politico

NBC pundit, public health expert Vin Gupta in line for top Biden administration spot

FDA eyes the media-savvy adviser to improve agency’s PR efforts after recent stumbles.

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