The decision by a Texas judge to overturn F.D.A. approval for the abortion pill mifepristone could upend the pharmaceutical industry.
Category: Food and Drug Administration
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Pfizer CEO and Other Drug Company Leaders Condemn Texas Abortion Pill Ruling
More than 250 executives said that the decision ignored both scientific and legal precedent and, if it stands, would create uncertainty for the pharmaceutical and biotech industries.
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Abortion Ruling Could Undermine the F.D.A.’s Drug-Approval Authority
Legal scholars say the ruling by a Texas judge, if upheld, could spur disputes over many medications and upend the drug industry’s reliance on the agency.
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What’s Going On With the Abortion Pill Rulings by Federal Judges?
One invalidated the F.D.A.’s approval of the abortion pill mifepristone. The other ordered the F.D.A. to do nothing to restrict the pill’s availability.
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Texas Judge Invalidates FDA Approval of the Abortion Pill Mifepristone
The Texas judge’s ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available.
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Over-the-Counter Narcan Could Save More Lives. But Price and Stigma Are Obstacles
The New York Times – Business:The Food and Drug Administration is expected this week to allow the overdose-reversal medication to be sold without a prescription, a step toward making it a common emergency tool.
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These Devices Sickened Hundreds. The New Models Have Risks, Too.
The New York Times – Business:Duodenoscopes — tubular cameras threaded into the intestine — with disposable parts were supposed to be safer. But the parts can fall off in the body, the F.D.A. warned.
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Rising Rate of Drug Shortages Is Framed as a National Security Threat
The New York Times – Business:A Senate homeland security committee examined growing health care shortages amid reports of rationing within hospitals.
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Frozen Strawberries Recalled Over Hepatitis A Risk
The New York Times – Business:The products, which were sold at Trader Joe’s, Costco, Aldi and other retailers, have been linked to five cases of illness, a federal agency said.
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F.D.A. Advisers Endorse Paxlovid’s Benefits as a Covid Treatment
The New York Times – Business:While an agency analysis did find signs of Covid “rebound,” the drug significantly reduces hospitalizations and deaths, researchers said.
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What to Know About the Recent Eye Drop Recalls
The New York Times – Business:Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least one death. Two more companies have since recalled eye drops.
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Lawyers to Face Off Before Judge in Closely Watched Abortion Pills Case
The New York Times – Business:The first hearing in a lawsuit that seeks to overturn F.D.A. approval of the pills takes place Wednesday morning in Texas.