Category: fda

FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men

Federal regulations prevent gay and bisexual men from donating tissue, such as corneas, ligaments, and blood vessels. Similar restrictions have been relaxed or lifted for donated blood and organs in recent years.

FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device

Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm. The company had “never” reported any complaints about its products to the FDA, according to the agency.

What’s Keeping the US From Allowing Better Sunscreens?

A decade after Congress told the FDA to expedite the approval of more effective sunscreens, the federal government still has not approved sunscreen ingredients that are safely being used around the world. Meanwhile, skin cancer is the nation’s most common cancer.

Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge

The FDA told Amgen to test whether a quarter-dose of its lung cancer drug worked as well as the amount recommended on the product label. It did and with fewer side effects. But Amgen is sticking to the higher dose — which earns it an additional $180,000 a year per patient.

Bird Flu Is Bad for Poultry and Dairy Cows. It’s Not a Dire Threat for Most of Us — Yet.

Cattle across the country are infected by the H5N1 bird flu. The virus isn’t spreading among people — but if it evolves to do that, fears of another pandemic could be realized.

KFF Health News’ ‘What the Health?’: Abortion Access Changing Again in Florida and Arizona

A six-week abortion ban took effect in Florida this week, dramatically restricting access to the procedure not just in the nation’s third-most-populous state but across the South. Patients from states with even more restrictive bans had been flooding in since the overturn of Roe v. Wade in 2022. Meanwhile, the CEO of the health behemoth UnitedHealth Group appeared before committees in both the House and Senate, where lawmakers grilled him about the February cyberattack on subsidiary Change Healthcare and how its ramifications are being felt months later. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Rachana Pradhan of KFF Health News join KFF Health News’ Julie Rovner to discuss these stories and more. Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too.

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.

Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company

Most of the doctors the FDA tapped to advise it on an Abbott medical device had financial ties to the company. The FDA didn’t disclose the payments.

A New $16,000 Postpartum Depression Drug Is Here. How Will Insurers Handle It?

A pill form of an effective drug for postpartum depression hit the market in December, but most insurers do not yet have a policy on when or whether they will pay for it. The hurdles to obtain its predecessor medication have advocates worried.