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The Latest Breaking News from Food and Drug Administration

Supreme Court preserves FDA rules for access to abortion pill – but only temporarily

The decision that overturned the FDA’s approval of mifepristone is on hold as the nation’s high court considers the case

The Independent UK

All eyes on SCOTUS for abortion pill ruling

A decision could come Friday — and could effectively override the Food and Drug Administration's decision-making.

Axios

Appeals court allows limited access to abortion pill

A federal appeals court partly granted the Biden administration’s request to put on hold a Texas court ruling overturning FDA approval of the abortion pill, but allowed restrictions that were lifted since 2016 to be reinstated.

Tribune News Service

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Lisa Jarvis: Abortion pill ruling threatens pharmaceutical innovation

A Texas federal judge’s ruling to remove the 23-year-old drug mifepristone from the market not only threatens abortion access in the U.S. — it’s also an appalling sideswipe at the Food and Drug Administration’s authority and expertise.

Tribune News Service

Abortion drug rulings spur drugmaker worries about precedent

WASHINGTON — Experts worry two recent rulings challenging the Food and Drug Administration’s regulation of a drug used in medication abortions threaten to complicate the agency’s oversight and the pipeline for future research and drug approvals.

Tribune News Service

Ask the Doctors: Botox injections one way to treat excessive sweating

Hyperhidrosis is excessive perspiration that isn’t associated with exercise, temperature or other typical triggers.

Chicago Sun-Times

Eyedrops maker couldn't ensure factory was sterile, FDA says

The Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops

The Independent UK

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Cynthia M. Allen: Texas abortion pill case is no morality play. It’s a complex, technical squabble

Since a group of pro-life plaintiffs first challenged the Food and Drug Administration’s approval of mifepristone, one of the two drugs used in chemical or medication abortions, the reporting on the case has been predictable.

Tribune News Service

Should Scientists Use "Race" as a Proxy for Genetics?

Nature, last month (paywall): The US Food and Drug Administration (FDA) will soon require [based on new federal legislation] researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants…. The diversity requirement arrives in the wake of a 2022 report from…

Reason

Commentary: Banning abortion pill mifepristone would be a terrible policy choice and violate human rights

Patients’ access to lifesaving medicine is under threat because an anti-abortion rights organization sued in federal district court to overrule the Food and Drug Administration’s approval of mifepristone, which has been used to terminate early pregnancies for almost a quarter century in the U.S. If the judge, appointed by the…

Chicago Tribune

Oat and soy can be called milk, FDA proposes

Dairy producers for years have called for the FDA to crack down on plant-based drinks and other products that they say masquerade as animal-based foods and cloud the real meaning of “milk.”

Chicago Sun-Times

FDA has new leverage over companies looking for a quicker drug approval

The Food and Drug Administration has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.

WEKU

An FDA panel has recommended a 2-dose RSV vaccine for older Americans. Here’s when they might be able to get it

The jabs could be ready as soon as this summer, one expert tells Fortune.

Fortune

An at-home COVID-19 and flu test gets FDA emergency use authorization

The Food and Drug Administration has approved an at-home test that can detect and discern between COVID-19 infection and two strains of the flu, Influenza A and B, continuing the shift from clinical to home-diagnostic care that blossomed during the height of the pandemic.

Tribune News Service

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Tribune News Service

Noah Feldman: New pro-choice abortion pill lawsuit is a gamble

As a Texas federal judge mulls whether to halt the Food and Drug Administration’s longstanding approval of an abortion pill, 12 liberal states have filed a separate lawsuit in a federal district court in Washington state that seeks to force the FDA to drop some restrictions on the drug.

Chicago Sun-Times

FDA authorizes first at-home combination test for COVID and flu

The Lucira COVID-19 and Flu Home Test is a single-use test, which can be purchased without a prescription.

WEKU

Washington state attorney general says FDA rules on abortion drug are unreasonable

A coalition of state attorneys general is suing the Food and Drug Administration over its regulation of mifepristone. NPR's Michel Martin speaks with Washington state Attorney General Bob Ferguson.

Tribune News Service

FDA warns of Guillain-Barre syndrome as possible risk of Pfizer’s RSV vaccine

The Food and Drug Administration has flagged Guillain-Barre syndrome, a rare neurological condition, as a potential risk for Pfizer’s respiratory syncytial virus vaccine.

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The Independent UK

FDA authorises first ever flu-Covid home test

The Food and Drug Administration has approved the first combination test for flu and COVID-19 that can be used at home, giving consumers an easy way to determine if a runny nose is caused by either disease

The Independent UK

FDA authorizes combination flu-COVID test for home use

Tribune News Service

FDA plans oversight changes after critical tobacco report

The Food and Drug Administration on Friday announced a series of actions meant to improve its oversight of tobacco and nicotine products, most notably e-cigarettes.

WEKU

Democratic state attorneys general sue Biden administration over abortion pill rules

The suit comes as a federal judge in another case is considering whether to overturn FDA approval of the same drug, mifepristone.

The Independent UK

FDA's tobacco unit pledges reset after criticism

The Food and Drug Administration is pledging a reset in the agency’s tobacco program

Tribune News Service

FDA expands contaminated eye product warning due to potential bacterial contamination, risk of blindness

The Food and Drug Administration is adding to a list of eye-care products consumers should stop using “immediately” over concerns of possible bacterial contamination that could lead to blindness if infection occurs.

Tribune News Service

What is naloxone and should everyone have access to it?

Two panels that advise the Food and Drug Administration are recommending that naloxone nasal spray be approved for over-the-counter sale for emergency treatment of opioid overdoses. The Joint Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously to approve the measure. The FDA will…

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