Category: Food and Drug Administration

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.
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.
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.
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.
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.
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.
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.
F.D.A. Approves New Nasal Spray for Migraines

The New York Times – Business:
Pfizer’s treatment applies an approach that is different from some other products, which doctors say may make it safer for people at risk of heart attacks or stroke.
Preterm Birth Drug Withdrawn After 12 Years

The New York Times – Business:
The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.
Walgreens Faces Blowback for Not Offering Abortion Pill in 21 States

The New York Times – Business:
The chain’s situation shows the complicated legal and reputational landscape that it and its competitors must navigate in the post-Roe era.
Why Lawmakers Aren’t Rushing to Police A.I.

The New York Times – Business:
Artificial intelligence tools are proliferating throughout society, and getting more powerful. Washington has failed to keep pace.
FDA Panel Recommends 2 RSV Vaccines for Older Adults

The New York Times – Business:
The shots, if approved by the agency, would be the first vaccines publicly available against a respiratory virus that kills thousands a year. Some advisers did cite a small but identifiable health risk.