FDA
publication date
Pharma
Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge
The heavier dosage allows AmGen to protect 75% of its revenue from the drug, which earned $200 million last year.
Pharma
Opioid Maker Endo Health Solutions to Pay $1.1B, Forfeit $450M
It's the second-largest criminal financial penalty levied against a drug maker.
Payer
FDA Finally Moves to Scrutinize Specialized Health Screenings
The agency issued a rule that brings new scrutiny to a range of critical lab-developed tests, including certain cancer and...
Pharma
FTC IDs 300+ 'Junk Patents' Among Drugmakers
The warning letters don't specify how the drugmakers are flouting patent regulations, or what criteria the FTC uses to make...
Innovation
Understanding the Value of the Home as a Healthcare Site
A new FDA program aims to develop strategies and guidelines for health systems delivering care in the patient?s home
Marketing
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
This week's alert is the second Class 1 recall of a HeartMate device this year.
Payer
New Report Targets Payer Pain Points for Digital Therapeutics Integration
The Digital Therapeutics Alliance is helping outline integrated digital product workflows that identify gaps for payers, clinicians, and patients.
CEO
At Stake in Mifepristone Case: Abortion, FDA's Authority, and Return to 1873 Obscenity Law
A victory for the plaintiffs would lay the groundwork for a de facto nationwide abortion ban.
Technology
AI Coalition Pushes Forward With Governance Plans
The Coalition for Health AI (CHAI) is staking its claim as the industry?s best option for creating meaningful and acceptable...
Innovation
FDA Issues Alert on Smartwatches, Smart Rings for Diabetes Management
The agency is warning that no devices have been approved that can accurately measure a user?s blood glucose without piercing...
Technology
FDA Repeatedly Rejected Safety Claims Made by Philips After the CPAP Recall but Waited to Alert the Public, Emails Show
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company...
Innovation
FDA's Robert Califf on AI in Healthcare: 'It's a Different World'
As health system execs attending CES 2024 talked of using AI to address specific challenges, the FDA commissioner pointed out...