ROBERT CALIFF

The FDA said the policy would shift to an individual assessment that evaluates an individual's risk regardless of gender sexual orientation.

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

Lead exposure can impair brain development and the nervous system, resulting in learning disabilities, lower IQ and behavioral difficulties.

FDA Commissioner urges parents not to stockpile children’s flu meds amid shortages

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

Young children are now eligible to get the latest COVID-19 vaccine booster. Children can get a single bivalent booster two months after completing their two-dose primary series with the original, monovalent COVID vaccine from Moderna. Bivalent COVID vaccines have been available since September, and more than 1.33 million Michigan residents have since been boosted. Both bivalent shots include an mRNA component corresponding to the original strain of coronavirus, plus an mRNA component corresponding to the omicron variants BA.4 and BA.5. To find a vaccine provider near you, visit vaccines.gov/search, input your ZIP code, and select one or both of the bivalent COVID-19 vaccines.

The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs.

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 FDA cleared Upside Foods to use animal cell culture technology to take living cells from chickens and produce cultured animal cell food.

A panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work.

U.S. regulators have revealed their plan to allow foreign baby formula manufactures to stay on the market long term.

The new chief at the Food and Drug Administration's tobacco center has inherited a raft of problems.

The FDA will also seek new authority to compel companies to turn over key information.

“To a large extent that’s what happened here.”Califf said the FDA will seek new authority to compel companies to turn over key information. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”The FDA report was overseen by a senior official who interviewed dozens of agency staffers. It comes nearly eight months after the FDA shuttered Abbott’s Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

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.

Republicans said in a letter to the FDA commissioner that the agency needs to explain its internal procedures for investigating food safety matters

U.S. health officials are warning doctors against overusing the lone drug available to treat monkeypox.

Pfizer and Moderna have released a new COVID booster shot that will target the highly contagious BA.4 and BA.5 omicron variant.

CDC director Dr. Rochelle Walensky says new BA.5-specific Covid booster shots need to roll out quickly, even if they aren't fully tested in humans yet. Here's why.

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.

One maker of the fruit-flavored candies halts sales after FDA issues first-of-a-kind warning of potential toxicity.

U.S. regulators have issued a warning letter to the maker of illegal nicotine gummies.

The Jynneos vaccine can now be administered between layers of skin instead of underneath layers, allowing for a smaller dose.

A Mississippi grand jury has declined to indict the white woman whose accusation set off the lynching of the Black teenager Emmett Till nearly 70 years ago, most likely closing the case that shocked a nation and galvanized the modern civil rights movement.

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.

The latest data shows nearly one-third of powdered formula products are still out of stock nationwide.

The FDA's tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues.

The head of the Food and Drug Administration is asking for a review of the agency’s food and tobacco programs.

The U.S. is getting another COVID-19 vaccine choice.

Abbott Nutrition says baby formula production has resumed at the Michigan plant whose February shutdown over contamination contributed to a national shortage.

Before shots can be administered to kids as young as 6 months old, the CDC's vaccine advisers are scheduled to vote on updated recommendations this Saturday.

Less than two weeks after restarting formula production at its Michigan facility, Abbott has again had to halt manufacturing there amid flooding.

Abbott has stopped production of EleCare formula in its Sturgis, Michigan, plant after severe storms led to flooding inside the plant, the company said, probably delaying production of new formula for a few weeks.

U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020.

Abbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage.

Dearborn officials are holding an emergency baby formula distribution event on Friday, spurred by a nationwide formula shortage.

FDA Commissioner Dr. Robert Califf said it will take about two months for shelves to be full with formula again.

Commissioner Robert Califf admitted the agency's reaction was "too slow," while a formula maker exec apologized to parents.

Sluggish response and questionable decisions by the Food and Drug Administration exacerbated the nation's infant formula shortage, officials say.

Abbott Nutrition and U.K.-based Kendal Nutricare plan to ship more than 2 million cans of formula.

Abbott Nutrition and U.K.-based Kendal Nutricare plan to ship more than 2 million cans of formula.

The FDA and President Joe Biden face mounting political pressure to explain why they didn't intervene earlier to try and address the supply problems.

The FDA and President Joe Biden face mounting political pressure to explain why they didn't intervene earlier to try and address the supply problems.

Members of Congress began a House subcommittee hearing Tuesday by accusing north suburban-based Abbott Laboratories of negligence

FDA Commissioner Robert Califf will answer questions from House lawmakers about what's caused the formula shortage.

The House Oversight and Investigations subcommittee hearing will begin at 11 a.m.

The head of the Food and Drug Administration testified about a series of setbacks that led to a months-long delay in inspecting the plant at the center of a nationwide baby formula shortage.

WASHINGTON — U.S. Food and Drug Commissioner Robert Califf told Congress Thursday that the infant formula shortage will likely begin to improve in the coming...

But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.

FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden. The problems are largely tied to Abbott Nutrition’s Michigan formula plant, the largest in the U.S., which has been closed since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications. Abbott shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The baby formula shortage is the first major crisis for Califf since returning to the FDA in February.

The FDA closed the plant in February — after four infants who drank formula produced there contracted bacterial infections, two of whom died.

Republicans argued that the plan didn't force federal agencies to look for formula that could be redirected to U.S. homes immediately.

The Food and Drug Administration's commissioner says a shuttered baby formula factory could be up and running by next week.

The head of the Food and Drug Administration told lawmakers Thursday that a shuttered baby formula factory could be up and running as soon as next week, though he sidestepped questions about whether his agency should have intervened earlier...

At the center of the nationwide baby formula shortage is a single factory: Abbott Nutrition's plant that has been closed for more than three months because of contamination problems.

At the center of the nationwide baby formula shortage is a single factory: Abbott Nutrition's plant that has been closed for more than three months because of contamination problems.

House Democrats have unveiled a $28 million emergency spending bill to address the shortage of infant formula in the United States.

The Food and Drug Administration on Tuesday authorized a Pfizer booster dose for children ages 5 through 11 years old at least five months after they complete their two-dose primary series. Dr. Peter Marks, head of the FDA division responsible for vaccines, said data increasingly shows that the protection provided by two shots wanes off over time. The FDA determined that a third shot can help boost protection for children in this age group and the benefits outweigh the risks, Marks said. The FDA did not convene its committee of independent experts to discuss the data before authorizing the booster dose. New hospital admissions of people with Covid have also increased 8% over the past week, according to the CDC.

The U.S. Food and Drug Administration has granted emergency use authorization for a booster dose of Pfizer/BioNTech's COVID-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series.

Abbott, one of the largest formula-makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported formula.

President Joe Biden's administration has announced new steps to ease the national shortage of baby formula, including allowing more imports from overseas.

States have been asked to increase accessibility of baby formula for recipients of the low-income program. And the Food and Drug Administration is looking at ways to make it easier to import formula.

The U.S. government has released its long-awaited plan to ban menthol cigarettes and flavored cigars.

Vacant high-ranking positions across the executive branch could be taking a toll on the Biden administration.

The Senate voted on Tuesday to confirm Dr. Robert Califf to head the agency on a 50-46 vote. The agency has been without a permanent leader for the last 13 months.

Califf already served as FDA commissioner under the Obama administration.

Robert Califf testifies during the Senate Health, Education, Labor and Pensions Committee hearing on the nomination to be commissioner of the Food and Drug Administration on Tuesday, Dec. 14, 2021. The Senate narrowly confirmed Dr. Robert Califf as Food and Drug Administration commissioner on Tuesday, over objections to his pharmaceutical industry ties and concerns he would not act aggressively enough to stem the opioid epidemic. "Dr. Califf is a supremely qualified nominee with bipartisan support," said Sen. Richard Burr, the ranking Republican on the Senate health committee, before Tuesday's vote. Califf is a prominent cardiologist with extensive clinical research experience who served as FDA commissioner during President Barack Obama's final year in office. Biden has said Califf will bring a steady hand to the FDA as the drug regulator faces urgent decisions on Covid vaccines, therapeutics and testing to fight the pandemic.

The Senate has narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration, filling a position that had been open for more than a year.

President Joe Biden’s pick to lead the powerful Food and Drug Administration has stalled in the narrowly divided Senate.

President Joe Biden’s pick to lead the Food and Drug Administration parried questions on crises ranging from the COVID pandemic to the opioid epidemic at his confirmation hearing Tuesday.

Dr. Califf served as FDA commissioner for the last 11 months of President Barack Obama's second presidential term.

Dr. Califf served as FDA commissioner for the last 11 months of President Barack Obama's second presidential term.

Califf, a cardiologist, was briefly the agency's commissioner under the Obama administration beginning in 2016.

President Joe Biden is nominating former Food and Drug Administration commissioner Dr. Robert Califf to again lead the powerful regulatory agency.

Califf served as FDA commissioner under former President Obama.

President Joe Biden is close to nominating former Food and Drug Administration Commissioner Dr. Robert Califf to lead the agency once again, the Washington Post reported Thursday. An Obama appointee, Califf helmed the FDA from February 2016 to February 2017 after a year as the agency's deputy commissioner for medical products and tobacco, according to the agency's website. His nomination would mark the end of a nine-month search for a permanent replacement for Acting Commissioner Dr. Janet Woodcock, who took over the agency on an interim basis in January. Biden must nominate Woodcock or choose another full-time commissioner by mid-November, the Post reported. A White House official told the Washington Post that Biden had not yet made his selection, while Califf declined to comment.

Full approval of Pfizer or Moderna's vaccines will embolden employers to mandate the shots and the companies to advertise on TV.