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☆ FDA proposal would allow gay men in monogamous relationships to donate blood
▼ + stars: | 2023-01-27 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Under the guidelines proposed on Friday, gay and bisexual men who are in monogamous relationships would be allowed to donate blood. The FDA had imposed a lifetime ban on men who have sex with men donating blood during the AIDS crisis in the 1980s. The agency had eased the ban in 2015, allowing gay and bisexual men to donate blood if they had not had sex in the previous year. The American Medical Association had criticized the FDA's restrictions on gay men donating as discriminatory. Those taking injections to prevent HIV would not be allowed to donate blood for two years following their most recent injection.

☆ FDA official overseeing food policy and response to resign in wake of baby formula shortage
▼ + stars: | 2023-01-26 | by ( Zoë Richards | Zoë Richards Is The Evening Politics Reporter For Nbc News. | ) www.nbcnews.com time to read: +2 min

Frank Yiannas, a top official at the Food and Drug Administration in charge of the agency's food policy and response office, announced Wednesday that he is stepping down from his role as deputy commissioner. His resignation comes days after Abbott Laboratories confirmed that the Justice Department was investigating the company over its Michigan baby formula plant. "Today, I informed Commissioner [Robert] Califf that I will be resigning my position as Deputy Commissioner for the Office of Food Policy and Response effective February 24 ," Yiannas tweeted. Yiannas' resignation announcement comes weeks after an expert panel issued a scathing report on its investigation of the FDA's processes and organizational structure for its foods program. That investigation, was ordered by FDA Commissioner Robert Califf in July, following growing criticism that the agency had mishandled the formula crisis after illnesses were reported.

☆ FDA proposes new lead limits for baby food to reduce potential risks to children’s health
▼ + stars: | 2023-01-24 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration proposed new limits Tuesday on lead in baby food, in an effort to reduce exposure to a toxin that can impair childhood development. The lead limits apply to processed food consumed by children younger than two years old. In a statement, FDA Commissioner Dr. Robert Califf said the limits would reduce lead exposure from these foods by as much as 27%. This would reduce exposure by 26%. Lead exposure through food among children ages 1 to 3 has declined 97% since the 1980s, according to the FDA.

☆ FDA Commissioner Denies Wrongdoing in Approval Process for Biogen Alzheimer’s Drug Aduhelm
▼ + stars: | 2023-01-11 | by ( Liz Essley Whyte | ) www.wsj.com time to read: +1 min

FDA Commissioner Robert Califf says a high level of interaction between agency officials and drug companies helps cut down on applications for drugs that don’t work. U.S. Food and Drug Administration Commissioner Robert Califf defended his agency’s decision to approve the Alzheimer’s drug Aduhelm, after an investigation by House Democrats found close cooperation between the drug’s sponsor and regulators. Findings released late last year from the then-Democratic-led Oversight and Reform Committee and the Energy and Commerce Committee faulted the FDA for holding an unusual number of meetings with Biogen Inc. while it weighed approval of Biogen’s Alzheimer’s treatment, Aduhelm, as well as for co-authoring with the company a briefing document presented to outside advisers. The FDA granted preliminary approval to Aduhelm in 2021, but Medicare officials refused to cover it routinely, dooming the company’s plans for profits.

☆ CMS limiting coverage of Alzheimer's drug not a 'fixed' policy, says FDA's Robert Califf
▼ + stars: | 2023-01-10 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailCMS limiting coverage of Alzheimer's drug not a 'fixed' policy, says FDA's Robert CaliffCNBC's Meg Tirrell and Dr. Robert Califf, FDA commissioner, joins 'Power Lunch' to discuss Biogen's Alzheimer's drug and the health care sector.

☆ Omicron XBB.1.5 is rising in U.S. though revised CDC data shows slower increase than previously reported
▼ + stars: | 2023-01-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

XBB.1.5 made up 27.6% of sequenced Covid cases nationally for the week ending Jan. 7 compared with 18.3% for the week end Dec. 31. The CDC previously reported that XBB.1.5 made up about 41% of sequenced cases for the week ending Dec. 31, more than any other variant. Although the agency has revised its estimate downward, XBB.1.5 remains the only omicron subvariant showing significant growth in the U.S. right now. U.S. health officials should have more data soon on how much protection the omicron boosters provide against XBB.1.5., Jha said. Weekly Covid cases have increased by about 16% to 470,699 over the past week, according to CDC data.

☆ FDA Commissioner urges parents not to stockpile children’s flu meds amid shortages
▼ + stars: | 2022-12-21 | by ( Bertha Coombs | ) www.cnbc.com time to read: +3 min

The Commissioner of the Food and Drug Administration says his agency is working with producers to improve supply, but the current demand is unprecedented. And if people buy more than they need and everybody does that, then people who need the products won't be able to get them," FDA commissioner Dr. Robert Califf told CNBC. This week CVS Health began limiting purchases to two children 'over-the-counter pain and fever relief medication items in-store and online. The FDA commissioner says his agency is working with manufacturers to make sure that necessary supply of children's meds reach the areas where they are most needed. "We've not seen the need the demand nearly as high as it is now at any time in our recorded history."

☆ FDA needs to do better at policing online tobacco retailers, new report says
▼ + stars: | 2022-12-09 | by ( Jen Christensen | ) edition.cnn.com time to read: +6 min

CNN —The US Food and Drug Administration is falling down on the job of policing online tobacco retailers, according to a highly critical new report from the US Department of Health and Human Services’ Office of Inspector General. “It is unclear to what extent FDA conducted additional oversight of these online tobacco retailers at later dates and found subsequent violations that could result in FDA taking enforcement actions,” the report says. While it can be difficult to police online retailers due to the sheer volume and the internet’s “wild West” nature, as one FDA official described it in the report, it says the FDA could do better by collaborating more closely with ATF on the oversight of these online retailers. The report recommends that the FDA finish making rules about online sales, as it was supposed to do years ago, and collect data about its oversight of online retailers. What stood out to Sward in the report was the FDA’s lack of follow-up beyond warning letters to online retailers.

☆ FDA authorizes Covid omicron vaccines for children as young as 6 months old
▼ + stars: | 2022-12-08 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

REUTERS/Shannon StapletonThe Food and Drug Administration on Thursday authorized updated Covid shots that target the omicron variant for children as young as 6 months old. The eligibility rules vary depending on whether children received Moderna's or Pfizer's original vaccines as their primary series. The new shots target the omicron BA.5 subvariant and the original Covid strain. U.S. health officials expect the new shots to provide superior protection compared to the original vaccines, which only target the original Covid strain. The FDA authorized the shots based on adult immune response data for similar vaccines developed by Pfizer and Moderna that target the original omicron BA.1 variant.

☆ Children as young as 6 months can now receive an updated Covid-19 vaccine
▼ + stars: | 2022-12-08 | by ( Jamie Gumbrecht | ) edition.cnn.com time to read: +2 min

CNN —Children as young as 6 months are now eligible to receive an updated Covid-19 vaccine. The US Food and Drug Administration on Thursday authorized updated Covid-19 vaccines from Moderna and Pfizer/BioNTech for use in children from ages 6 months through 5 years. Not all young children are eligible to receive an updated vaccine:Children age 6 months through age 5 who received the original, two-dose Moderna vaccine are eligible to receive a single booster of the updated bivalent Moderna vaccine two months after completing the primary vaccine series. Children age 6 months through 4 years who haven’t started their three-dose primary series of the Pfizer vaccine or received the third dose will receive the updated Pfizer vaccine as the third dose of the primary series. The data to support giving an updated bivalent booster dose for these children are expected in January.

☆ In wake of baby formula crisis, critical report recommends major food safety changes at FDA
▼ + stars: | 2022-12-06 | by ( Jen Christensen | ) edition.cnn.com time to read: +10 min

It enforces food safety regulations, works with local governments on food safety information, promotes dietary guidelines, and develops food safety information and education, as well as overseeing nutrition labels on most food and being responsible for promoting good nutrition practices to the US public. Another would have the FDA develop a strategy to increase funding for the Human Foods Program, with help from Congress. “The current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal” of protecting public health,” the report says. “The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” Califf said in a news release. Some critics have suggested that food safety takes a back seat to the FDA’s regulations of drugs and medical devices.

☆ Former U.S. President Clinton tests positive for COVID
▼ + stars: | 2022-11-30 | by ( ) www.reuters.com time to read: 1 min

Nov 30 (Reuters) - Former U.S. President Bill Clinton said in a tweet on Wednesday that he has tested positive for COVID-19 and experiencing mild symptoms. "I'm grateful to be vaccinated and boosted, which has kept my case mild," he said. loadingFew weeks ago, U.S. Centers for Disease Control and Prevention (CDC) director Rochelle Walensky and U.S. Food and Drug Administration Commissioner Robert Califf had also tested positive with COVID symptoms. Reporting by Akriti Sharma and Khushi Mandowara in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ FDA says lab-grown meat is safe for human consumption
▼ + stars: | 2022-11-17 | by ( Emma Newburger | ) www.cnbc.com time to read: +1 min

The Food and Drug Administration for the first time cleared a lab-grown meat product developed by a California start-up as safe for human consumption, marking a key milestone for cell-cultivated meats to eventually become available in U.S. supermarkets and restaurants. The FDA cleared Upside Foods, formerly known as Memphis Meats, to use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to produce cultured animal cell food. The agency said it evaluated Upside Food's production and cultured cell material and has "no further questions" about the safety of its cultivated chicken filet. The company will be able to bring its products to market once it's been inspected by the U.S. Department of Agriculture. "The world is experiencing a food revolution and the U.S. FDA is committed to supporting innovation in the food supply," FDA Commissioner Robert Califf and Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, said in a statement.

☆ Lab-grown meat is OK for human consumption, FDA says
▼ + stars: | 2022-11-17 | by ( Katie Hunt | ) edition.cnn.com time to read: +3 min

CNN —The US Food and Drug Administration has given a safety clearance to lab-grown meat for the first time. Upside Foods, a California-based company that makes meat from cultured chicken cells, will be able to begin selling its products once its facilities have been inspected by the US Department of Agriculture. Advocates hope that cultured meat will reduce the need to slaughter animals for food and help with the climate crisis. “At scale, cultivated meat is projected to use substantially less water and land than conventionally-produced meat.”Although not technically an approval, the FDA said that a thorough pre-market consultation process had been completed. The clearance only applies to food made from cultured chicken cells by Upside, but the statement said the FDA “is ready to work with additional firms developing cultured animal cell food.”

WASHINGTON, Nov 16 (Reuters) - The U.S. Food and Drug Administration (FDA) for the first time cleared a meat product grown from animal cells for human consumption, the agency announced on Wednesday. "We are thrilled at FDA's announcement," said David Kay, UPSIDE's director of communications, in an email. USDA and FDA together regulate cell-cultured meat under a 2019 agreement between the two agencies. USDA will oversee the processing and labeling of cell-cultured meat products. Demand for alternatives to farmed meat has grown alongside awareness of the high greenhouse gas emissions of raising livestock.

☆ Abbott plans new $500 million infant formula facility as shortage continues
▼ + stars: | 2022-10-19 | by ( Katherine Dillinger | ) edition.cnn.com time to read: +3 min

CNN —Abbott Nutrition plans to build a $500 million nutrition facility for specialty and metabolic infant formulas, Chairman and CEO Robert Ford said Wednesday. The announcement comes as the US formula shortage continues and experts have called for more domestic production and diversity among suppliers. “We’re currently in the final stages of determining the site location and will work with regulators and other experts to ensure this facility is state-of-the-art and sets a new standard for infant formula production. More than 40% said they had only a week’s supply or less on hand. “We also boosted production in our global network to increase infant formula supply to the US.

☆ Hearing aids: What to know about buying them over the counter
▼ + stars: | 2022-10-17 | by ( Raenu Charles | ) edition.cnn.com time to read: +8 min

Younger individuals tend to overestimate their degree of hearing loss, while older individuals tend to underestimate their hearing loss,” Creed said. Hearing amplifiers magnify all sound, but hearing aids are customized to suit a person’s hearing needs. Hearing aids sold over the counter will be regulated on October 17, but hearing amplifiers are unregulated. If the product doesn’t say “OTC or over-the-counter hearing aid” on the primary display, it is not an FDA-regulated hearing aid. Tip 3: Know the difference between over-the-counter and prescriptionOver-the-counter hearing aids will be a great option for thousands of people in the mild-to-moderate stage of their hearing journey, but for some with more severe hearing loss, prescription hearing aids are still the only option.

☆ FDA acknowledges delays in response to baby formula shortage
▼ + stars: | 2022-09-22 | by ( The Associated Press | ) www.nbcnews.com time to read: +5 min

WASHINGTON — The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory. 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. U.S. inventories of baby formula have been improving, hitting in-stock rates above 80% last week, according to IRI, a market research firm. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

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