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Search resuls for: "Liz Essley Whyte"


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☆ Baby-Formula Imports to Face Tariffs Again in 2023
  + stars: | 2022-12-28 | by ( Liz Essley Whyte | Kristina Peterson | Jesse Newman | ) www.wsj.com   time to read: 1 min
Imported baby formula will be subject to tariffs again in the new year, after the expiration of exemptions implemented amid a nationwide shortage. Congress waived tariffs, which can be as high as 17.5%, to help families struggling to find formula after supply-chain problems and the closure of a crucial factory crimped supplies. A White House spokesman said the tariff waivers doubled the number of manufacturers selling baby formula in the U.S. Congress made the tariff waivers temporary as part of a deal to pass the measures quickly, said people familiar with the matter.
☆ FDA, Concerned About Safety, Explores Regulating CBD in Foods, Supplements
  + stars: | 2022-12-27 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration is studying whether legal cannabis is safe in food or supplements and plans to make recommendations for how to regulate the growing number of cannabis-derived products in the coming months, agency officials said. “Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” said FDA Principal Deputy Commissioner Janet Woodcock , who has led the agency’s efforts looking at cannabis regulation.
☆ FDA Gains New Power to Oversee Cosmetics Industry
  + stars: | 2022-12-23 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration will soon have more regulatory authority after Congress passed its omnibus spending bill. Congress gave the Food and Drug Administration more power to regulate cosmetics, ensure fast-tracked drugs work and oversee infant formula supplies in its end-of-year spending bill. The legislation, a wide-ranging bill that authorized $1.65 trillion in federal government spending for fiscal 2023, addresses several gaps in the FDA’s regulatory powers that the agency, lawmakers and some industry groups had been seeking for years to fill.
☆ CDC Backs New Covid-19 Boosters for Youngest Kids
  + stars: | 2022-12-09 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Centers for Disease Control and Prevention signed off on certain young children receiving an updated Covid-19 booster, clearing the way for the shots to be widely available at pediatricians’ offices and other vaccination sites. The agency’s move on Friday was the last step before children as young as 6 months could get the shots, which were modified to target offshoots of the Omicron variant as well as the original strain of the virus.
☆ FDA Takes Tougher Line on Fast-Tracked Drugs
  + stars: | 2022-12-05 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration sometimes clears prescription medicines based on preliminary data but asks makers to conduct follow-up confirmatory studies. The Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK PLC, Roche Holdings AG and other drugmakers to remake plans for their drugs or pull them from the market. Under the accelerated-approval program, the FDA clears the use of prescription medicines faster than it normally would. The agency relies on preliminary data to make the decision, but asks companies to conduct follow-up studies to confirm that the drug works.
☆ Billions in Covid Aid Went to Hospitals That Didn’t Need It
  + stars: | 2022-12-04 | by ( Melanie Evans | Liz Essley Whyte | Tom Mcginty | ) www.wsj.com   time to read: 1 min
When Covid-19 struck, the U.S. government gave hospitals tens of billions of dollars to help them cope with the strains of the pandemic. Many of the hospitals didn’t need it.
☆ FDA Plans to Allow More Gay, Bisexual Men to Donate Blood
  + stars: | 2022-11-30 | by ( Liz Essley Whyte | Amy Dockser Marcus | ) www.wsj.com   time to read: 1 min
People donating at a blood drive hosted by the New York Blood Center in the East Village in New York. Gay and bisexual men in monogamous relationships would be allowed to donate blood without abstaining from sex under guidelines being drafted by the Food and Drug Administration, people familiar with the plans said. The change would be a departure from U.S. policy that for many years barred men who have sex with men from donating blood at all. The FDA policy originated in the 1980s during the AIDS epidemic when tests for HIV, the virus that causes AIDS, weren’t considered sensitive enough to protect the blood supply.
☆ FDA to Allow More Gay, Bisexual Men to Donate Blood
  + stars: | 2022-11-30 | by ( Liz Essley Whyte | Amy Dockser Marcus | ) www.wsj.com   time to read: 1 min
People donating at a blood drive hosted by the New York Blood Center in the East Village in New York. Gay and bisexual men in monogamous relationships would be allowed to donate blood without abstaining from sex under guidelines being drafted by the Food and Drug Administration, people familiar with the plans said. The change would be a departure from U.S. policy that for many years barred men who have sex with men from donating blood at all. The FDA policy originated in the 1980s during the AIDS epidemic when tests for HIV, the virus that causes AIDS, weren’t considered sensitive enough to protect the blood supply.
☆ Telehealth Companies Lobby to Extend Pandemic-Era Rules
  + stars: | 2022-11-25 | by ( Liz Essley Whyte | Rolfe Winkler | Brianna Abbott | ) www.wsj.com   time to read: +1 min
More than 100 groups have asked the DEA to create a registry of providers allowed to continue prescribing controlled substances online. Health startups and medical associations are lobbying for permanent permission to prescribe controlled substances remotely, part of a broader debate over the future of telehealth services that boomed during the pandemic. The push comes after some online startups faced scrutiny from lawmakers and pharmacies over their prescription practices. To maintain pandemic-era telehealth practices, more than 100 groups asked the Drug Enforcement Administration this month to create a registry of providers allowed to prescribe drugs online for conditions including opioid addiction. That would protect their operations when the Biden administration ends the Covid-19 public-health emergency, during which restrictions on telehealth have been relaxed.
☆ Lawsuit Filed to Reverse Approval, Access to Abortion Pill
  + stars: | 2022-11-18 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
A new abortion battle is moving to the courts, this time over a pill for ending pregnancies. Abortion opponents sued the Food and Drug Administration and Health and Human Services department in federal court in Amarillo, Texas, on Friday, seeking to undo the approval of the abortion-inducing pill called mifepristone as well as subsequent agency decisions easing access to the drug.
☆ FDA Advisers Recommend Pulling Drug to Prevent Preterm Births From Market
  + stars: | 2022-10-19 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration, in Silver Spring, Md., is expected to order the drug Makena removed from the market. Health experts advising the Food and Drug Administration recommended the agency pull from the market a drug used to prevent preterm births. The advisers voted against the FDA allowing Covis Pharma Group’s Makena to remain on the market, after the drug failed a trial to confirm its benefit.
☆ Covid-19 Boosters Targeting Omicron Authorized for Kids as Young as 5
  + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
U.S. health regulators on Wednesday expanded eligibility for the new Covid-19 booster shots to children as young as 5 years old, broadening access to help bolster protection against Omicron strains of the coronavirus. The U.S. Food and Drug Administration authorized the updated booster from Pfizer Inc. and its partner BioNTech SE for children ages 5 through 11, and Moderna Inc.’s updated booster for children 6 through 17.
☆ Covid-19 Boosters Targeting Omicron Authorized by FDA for Kids as Young as 5
  + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
U.S. health regulators on Wednesday expanded eligibility for the new Covid-19 booster shots to children as young as 5 years old, broadening access to help bolster protection against Omicron strains of the coronavirus. The U.S. Food and Drug Administration authorized the updated booster from Pfizer Inc. and its partner BioNTech SE for children ages 5 through 11, and Moderna Inc.’s updated booster for children 6 through 17.
☆ Omicron-Targeting Covid-19 Boosters Recommended for Kids as Young as 5
  + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
U.S. health regulators on Wednesday expanded eligibility for the new Covid-19 booster shots to children as young as 5 years old, broadening access to help bolster protection against Omicron strains of the coronavirus. The U.S. Food and Drug Administration authorized the updated booster from Pfizer Inc. and its partner BioNTech SE for children ages 5 through 11, and Moderna Inc.’s updated booster for children 6 through 17. Centers for Disease Control and Prevention Director Rochelle Walensky subsequently recommended use of the updated boosters in these age groups.
☆ When Is the Pandemic Over?
  + stars: | 2022-09-19 | by ( Liz Essley Whyte | Brianna Abbott | ) www.wsj.com   time to read: 1 min
Covid-19 cases, hospitalizations and deaths continue, but some world leaders are signaling that the viral illness might not be a global emergency much longer. President Biden said the pandemic was over in an interview with CBS’s “60 Minutes,” drawing criticism from some public-health experts. Four days prior, World Health Organization Director-General Tedros Adhanom Ghebreyesus said the pandemic was ongoing but that its end was in sight.
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