F.D.A. Clears Path for Over-the-Counter Hearing Aids

The agency issued a final rule that took years to complete and opens the door to cheaper, more accessible devices without a prescription or medical exam.

#ears-and-hearing, #food-and-drug-administration, #medical-devices, #regulation-and-deregulation-of-industry, #tests-and-examinations, #your-feed-healthcare

What the New C.D.C. Guidelines Mean for You

The new recommendations put the onus on individuals to protect themselves. Here’s how to navigate them.

#centers-for-disease-control-and-prevention, #contact-tracing-public-health, #coronavirus-2019-ncov, #education-k-12, #food-and-drug-administration, #masks, #quarantines, #tests-medical, #vaccination-and-immunization, #your-feed-science

U.S. Moves to Stretch Out Monkeypox Vaccine Supply

The approach would involve injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat.

#food-and-drug-administration, #health-and-human-services-department, #monkeypox, #united-states-politics-and-government, #vaccination-and-immunization

What is Tpoxx? The Monkeypox Treatment Drug That’s Hard to Get

Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted.

#centers-for-disease-control-and-prevention, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #monkeypox, #smallpox, #stockpiling, #your-feed-science

U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year

The Department of Health and Human Services delayed asking the manufacturer to process the bulk vaccine the government already owned into vials.

#bavarian-nordic-as, #becerra-xavier, #centers-for-disease-control-and-prevention, #drugs-pharmaceuticals, #food-and-drug-administration, #monkeypox, #vaccination-and-immunization

Breaking Nicotine’s Powerful Draw

Millions of smokers could be forced to confront the agony of nicotine withdrawal as the F.D.A. weighs calling for a drastic reduction in the addictive lure of cigarettes.

#addiction-psychology, #e-cigarettes, #food-and-drug-administration, #juul-labs-inc, #national-institute-on-drug-abuse, #recalls-and-bans-of-products, #research, #smoking-and-tobacco

How the U.S. Let 20 Million Monkeypox Vaccine Doses Expire

At the start of the monkeypox outbreak the U.S. stockpile contained just 2,400 doses of vaccine, a far cry from the more than 20 million it once held.

#bavarian-nordic-as, #biological-and-chemical-warfare, #centers-for-disease-control-and-prevention, #denmark, #food-and-drug-administration, #health-and-human-services-department, #monkeypox, #new-york-city, #smallpox, #terrorism, #united-states, #vaccination-and-immunization

Biden Administration Plans to Offer Updated Booster Shots in September

With reformulated shots from Pfizer and Moderna on the horizon, the F.D.A. has decided that Americans under 50 should wait to receive second boosters.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #united-states-politics-and-government, #vaccination-and-immunization

On Monkeypox, Health Secretary Says States ‘Need to Work With Us’

The suggestion that states need to do more seemed to startle state and local officials, who said in interviews that they are generally satisfied with the federal government’s response.

#becerra-xavier, #centers-for-disease-control-and-prevention, #epidemics, #federal-state-relations-us, #food-and-drug-administration, #monkeypox, #states-us, #united-states-politics-and-government, #vaccination-and-immunization

U.S. to Distribute 800,000 Doses of Monkeypox Vaccine

The doses were withheld pending an F.D.A. review, which has now been completed.

#bavarian-nordic-as, #epidemics, #factories-and-manufacturing, #food-and-drug-administration, #monkeypox, #preventive-medicine, #stockpiling, #vaccination-and-immunization, #your-feed-science

F.D.A. Tobacco Science Official Takes Job at Philip Morris

The agency official headed an office that plays a key role in deciding whether to approve e-cigarettes and other products aimed at reducing smoking.

#conflicts-of-interest, #e-cigarettes, #food-and-drug-administration, #holman-matt, #juul-labs-inc, #medicine-and-health, #philip-morris-companies-inc, #regulation-and-deregulation-of-industry, #smoking-and-tobacco

As Monkeypox Spread in New York, 300,000 Vaccine Doses Sat in Denmark

The federal government adopted a wait-and-see response to the monkeypox outbreak, calling for more vaccines to be delivered only after cases were growing exponentially.

#bavarian-nordic-as, #biomedical-advanced-research-and-development-authority, #centers-for-disease-control-and-prevention, #epidemics, #food-and-drug-administration, #health-and-human-services-department, #lgbtq-pride-month-us, #monkeypox, #new-york-city, #smallpox, #vaccination-and-immunization

Monkeypox Catches New York City Off Guard (Again)

Long lines for vaccines. Testing is slowed. Antivirals are held up. Treatment is easier for the privileged. Sound familiar?

#acquired-immune-deficiency-syndrome, #adams-eric-l, #centers-for-disease-control-and-prevention, #chelsea-manhattan-ny, #coronavirus-2019-ncov, #fire-island-ny, #food-and-drug-administration, #hells-kitchen-manhattan-ny, #michael-donnelly, #monkeypox, #new-york-city, #smallpox, #vaccination-and-immunization, #world-health-organization

F.D.A. to Weigh Over-the-Counter Sale of Contraceptive Pills

The first U.S. application for sale of a nonprescription birth control pill has taken on new meaning in the wake of the Supreme Court decision ending the constitutional right to abortion.

#birth-control-and-family-planning, #cadence-health-inc, #califf-robert-m, #dobbs-v-jackson-womens-health-organization-supreme-court-decision, #food-and-drug-administration, #hra-pharma

What the Biden Administration Could Do Now to Protect Abortion Rights

The most urgent step the federal government can take is to ensure access to medication abortion.

#abortion, #abortion-drugs, #birth-control-and-family-planning, #centers-for-disease-control-and-prevention, #centers-for-medicare-and-medicaid-services, #dobbs-v-jackson-womens-health-organization-supreme-court-decision, #drugs-pharmaceuticals, #federal-trade-commission, #food-and-drug-administration, #law-and-legislation, #medicine-and-health, #pregnancy-and-childbirth, #regulation-and-deregulation-of-industry, #states-us, #united-states, #united-states-politics-and-government, #women-and-girls

Removing Nicotine From Cigarettes Would Spell a Historic Shift in Tobacco Regulation

The tobacco industry has long claimed smoking was a choice, but that was never true.

#food-and-drug-administration, #nicotine, #smoking-and-tobacco

Vladimir Zelenko, 48, Dies; Promoted an Unfounded Covid Treatment

A self-described “simple country doctor,” he won national attention in 2020 when the White House embraced his hydroxychloroquine regimen.

#coronavirus-2019-ncov, #deaths-obituaries, #drugs-pharmaceuticals, #food-and-drug-administration, #hydroxychloroquine-drug, #kiryas-joel-ny, #research, #trump-donald-j, #zelenko-vladimir

Behind the Scenes, McKinsey Guided Companies at the Center of the Opioid Crisis

The consulting firm offered clients “in-depth experience in narcotics,” from poppy fields to pills more powerful than Purdue’s OxyContin.

#acquired-immune-deficiency-syndrome, #appalachian-region, #centers-for-disease-control-and-prevention, #consultants, #drug-abuse-and-traffic, #drug-enforcement-administration, #drugs-pharmaceuticals, #endo, #food-and-drug-administration, #johnsonjohnson, #mckinseyco, #opana, #opioids-and-opiates, #oxycontin-drug, #pain-relieving-drugs, #poppies, #purdue-pharma, #united-states

Abortion Pills Take the Spotlight as States Impose Abortion Bans

Demand for medication abortion is surging, setting the stage for new legal battles.

#abortion, #abortion-drugs, #becerra-xavier, #drugs-pharmaceuticals, #food-and-drug-administration, #garland-merrick-b, #states-us, #telemedicine, #your-feed-healthcare, #your-feed-science

How to Make Abortion Pills More Available Post-Roe

Medication abortion isn’t a magic solution to the likely end of Roe. But it can blunt the fallout.

#abortion, #abortion-drugs, #food-and-drug-administration, #roe-v-wade-supreme-court-decision, #telemedicine, #united-states

F.D.A. Orders Juul to Stop Selling E-Cigarettes

The agency ruled against the company’s application to stay on the market, a decisive blow to a once-popular vaping brand that appealed to teenagers.

#altria-group-inc, #e-cigarettes, #food-and-drug-administration, #juul-labs-inc, #medicine-and-health, #nicotine, #recalls-and-bans-of-products, #regulation-and-deregulation-of-industry, #smoking-and-tobacco, #teenagers-and-adolescence

F.D.A. Set to Propose Lower Nicotine Levels in Cigarettes

The move would be an effort to further wean Americans from addictive tobacco products and reduce smoking-related illnesses.

#addiction-psychology, #altria-group-inc, #cancer, #centers-for-disease-control-and-prevention, #deaths-fatalities, #e-cigarettes, #food-and-drug-administration, #lung-cancer, #medicine-and-health, #menthol, #nicotine, #smoking-and-tobacco, #your-feed-healthcare

F.D.A. Authorizes Moderna and Pfizer Covid Vaccines for Youngest Children

A recommendation from the C.D.C. director would be the final step before doses are rolled out for the roughly 20 million children under the age of 5.

#biontech-se, #children-and-childhood, #coronavirus-2019-ncov, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #united-states, #vaccination-and-immunization

F.D.A. Panel Recommends Pfizer and Moderna Vaccines for Youngest Children

States have already ordered millions of doses; if the agency authorizes them in the coming days, babies, toddlers and preschoolers could start receiving shots next week.

#biontech-se, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #vaccination-and-immunization, #walensky-rochelle

New Experimental Therapy for A.L.S. Approved in Canada

The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.

#amylyx-pharmaceuticals-inc, #amyotrophic-lateral-sclerosis, #canada, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #health-canada, #united-states, #your-feed-science

Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says

Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest children.

#biontech-se, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #vaccination-and-immunization

Moderna’s Covid Vaccine Is Effective in Children Under 6, F.D.A. Says

Outside experts will meet next week to decide whether to recommend that the agency authorize the vaccine for kids 6 months and older.

#children-and-childhood, #coronavirus-2019-ncov, #food-and-drug-administration, #moderna-inc, #vaccination-and-immunization

U.S. Will Airlift Baby Formula From Abroad as Shortages Grow Worse

The White House is facing new questions about whether it acted quickly enough after the leading baby formula plant shut down in February.

#abbott-laboratories, #airlifts, #baby-foods, #biden-joseph-r-jr, #food-and-drug-administration, #infant-formulas, #shortages, #united-states-politics-and-government

What Really Caused the Baby Formula Shortage

The recent shutdown of one of the largest production plants in the United States has sent families scrambling to find essential food for their children.

#abbott-laboratories, #audio-negative-sad, #audio-neutral-informative, #bacteria, #food-and-drug-administration, #infant-formulas, #shortages

Vaccinating Our Youngest Kids Shouldn’t Take This Long

The formula shortage came on the heels of this seemingly endless wait.

#centers-for-disease-control-and-prevention, #coronavirus-omicron-variant, #defense-production-act, #food-and-drug-administration, #infant-formulas, #internal-sub-only-nl, #parenting, #vaccination-and-immunization

F.D.A. Chief Details ‘Shocking’ Conditions at Baby Formula Plant

Agency inspectors found a leaking roof, standing water and cracked production equipment before a facility shutdown that led to major shortages.

#abbott-laboratories, #baby-foods, #bacteria, #califf-robert-m, #centers-for-disease-control-and-prevention, #food-and-drug-administration, #infant-formulas, #michigan, #shortages, #shutdowns-institutional, #supply-chain, #united-states-politics-and-government

Baby Formula Shortage Reveals Gaps in Regulation and Reporting

The government has ordered more safeguards at an Abbott Nutrition plant. But the lack of reporting requirements and limited testing make it hard to monitor the deadly bacterium that led to a recall.

#abbott-laboratories, #bacteria, #food-and-drug-administration, #food-contamination-and-poisoning, #infant-formulas, #product-tests, #recalls-and-bans-of-products, #regulation-and-deregulation-of-industry, #shortages, #sturgis-mich

U.S. Military Airlifts Baby Formula From Europe

A shipment that arrived on Sunday was the first of two intended to address shortages in the United States. Another shipment is set to arrive this week, the White House said.

#agriculture-department, #biden-joseph-r-jr, #food-and-drug-administration, #infant-formulas, #shortages, #vilsack-tom

Baby Formula Shortage Has an Aggravating Factor: Few Producers

With just a handful of companies making U.S. infant formula, a shutdown of Abbott’s plant had outsized impact on the supply.

#abbott-laboratories, #bobbie-baby-inc, #califf-robert-m, #davis-david-e, #discount-selling, #food-and-drug-administration, #gerber-products-co, #government-contracts-and-procurement, #infant-formulas, #international-trade-and-world-market, #modi-laura, #perrigo-company, #reckitt-benckiser, #shortages

White House Struggles to Explain Baby Formula Production Plan

A day after invoking the Defense Production Act to help alleviate a nationwide shortage, administration officials had few answers for how the law would lead to more supply.

#abbott-laboratories, #biden-joseph-r-jr, #defense-production-act, #food-and-drug-administration, #infant-formulas, #international-trade-and-world-market, #shortages, #united-states-politics-and-government

Biden Invokes Defense Powers in a Bid to Ease Formula Shortage

The president invoked the Defense Production Act to boost supply and directed federal agencies to use Defense Department planes to speed shipments of formula from overseas.

#abbott-laboratories, #food-aid, #food-and-drug-administration, #house-of-representatives, #infant-formulas, #law-and-legislation, #shortages, #united-states-politics-and-government

Since You’re Already Getting a Flu Shot, Why Not One for Covid, Too?

Scientists and federal health officials are debating plans to pair coronavirus and flu vaccinations in the fall.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #food-and-drug-administration, #united-states, #vaccination-and-immunization, #your-feed-science

House Democrats Release $28 Million Aid Bill to Address Formula Shortage

The money is intended to help the Food and Drug Administration increase its staff and prepare for future shortages of infant formula.

#delauro-rosa-l, #food-and-drug-administration, #house-of-representatives, #infant-formulas, #law-and-legislation, #shortages, #united-states-politics-and-government

The F.D.A. authorizes Pfizer-BioNTech boosters for children ages 5 to 11.

More than eight million of the 28 million children in that age group in the United States have received two vaccine shots.

#biontech-se, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

How Biden Could Alleviate the Baby Formula Shortage

Why is the wealthiest country in the world struggling to provide basic nutrition to so many children?

#abbott-laboratories, #antitrust-laws-and-competition-issues, #biden-joseph-r-jr, #defense-production-act, #food-and-drug-administration, #infant-formulas, #klobuchar-amy, #lee-michael-s-1971, #lobbying-and-lobbyists, #senate, #shortages, #united-states, #united-states-economy

F.D.A. and Abbott Reach Agreement on Baby Formula to Try to Ease Shortage

The company said if the agency approved reopening the plant, production could resume and store shelves would be restocked within several weeks.

#abbott-laboratories, #children-and-childhood, #food-and-drug-administration, #food-contamination-and-poisoning, #infant-formulas, #international-trade-and-world-market, #parenting, #recalls-and-bans-of-products, #shortages, #supply-chain, #your-feed-healthcare

F.D.A. Expected to Soon Clear Pfizer Booster for Children Ages 5 to 11

Given that the age group has the lowest coronavirus vaccination rate of all eligible Americans, public health experts are not expecting a rush for the booster.

#biontech-se, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #united-states, #vaccination-and-immunization

The Bloody Crossroads Where Conspiracy Theories and Guns Meet

The slaughter in a Black neighborhood in Buffalo is in line with a series of racist massacres that show no signs of abating.

#abortion, #birth-control-and-family-planning, #buffalo-ny, #democratic-party, #demonstrations-protests-and-riots, #elections-senate, #food-and-drug-administration, #gun-control, #infant-formulas, #mass-shootings, #republican-party, #supreme-court-us, #united-states-politics-and-government

Under Pressure to Act, White House Says It’ll Address Formula Shortage

Senior officials announced minor steps the administration would take to try to increase the supply of formula, even as they conceded that Americans might not see quick relief.

#biden-joseph-r-jr, #federal-trade-commission, #food-and-drug-administration, #gerber-products-co, #infant-formulas, #shortages, #target-corporation, #united-states-economy, #united-states-politics-and-government, #walmart-stores-inc

The F.D.A.’s Ban of Menthol Cigarettes Will Help Black Communities

The proposed ban on menthol cigarettes, long aimed at Black consumers, is crucial to reducing smoking, especially among young people.

#black-people, #bush-george, #congressional-black-caucus, #food-and-drug-administration, #hooks-benjamin-l, #menthol, #national-assn-for-the-advancement-of-colored-people, #race-and-ethnicity, #regulation-and-deregulation-of-industry, #reynolds-r-j-tobacco-co, #smoking-and-tobacco, #sullivan-louis-v, #united-states

A Baby Formula Shortage Leaves Desperate Parents Searching for Food

Some parents are driving hours at a time in search of supplies. Others are watering down formula or rationing it, hoping for an end to the shortage.

#abbott-laboratories, #breastfeeding, #diet-and-nutrition, #food-and-drug-administration, #infant-formulas, #recalls-and-bans-of-products, #san-antonio-tex, #shortages

Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says

A report sheds new light on Emergent executives’ own worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.

#coronavirus-2019-ncov, #emergent-biosolutions-inc, #food-and-drug-administration, #regulation-and-deregulation-of-industry, #vaccination-and-immunization, #workplace-hazards-and-violations

Why a Covid Vaccine Mandate for N.Y.C. Schoolchildren Is Unlikely Soon

Officials and some pediatricians worry the backlash against a mandate could keep children out of school.

#adams-eric-l, #children-and-childhood, #coronavirus-omicron-variant, #food-and-drug-administration, #new-york-state, #state-legislatures, #vaccination-and-immunization

FDA Further Limits Johnson & Johnson Covid Vaccine

The agency said the move reflected an updated analysis of the risk of a rare but serious blood-clotting condition in people who get the vaccine.

#coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #vaccination-and-immunization

Abortion Pills Will Be the Next Battleground in a Post-Roe America

Medication abortion allows patients to terminate early pregnancies at home. Some states are moving to limit it, while others are working to expand access.

#abortion, #abortion-drugs, #drugs-pharmaceuticals, #food-and-drug-administration, #roe-v-wade-supreme-court-decision, #states-us, #telemedicine, #women-and-girls, #your-feed-healthcare