FDA
publication date
CEO
Make America Healthy Again: An Unconventional Movement That May Have Found Its Moment
A cadre of health business leaders and nonmainstream doctors are influencing Trump's focus on health policy.
CEO
Trump's White House Return: Healthcare Safety Net Implications
Trump's victory will give a far broader platform to skeptics and critics of federal health programs and actions.
HLM Mastermind
FDA to Ramp Up Surveillance of Potentially Faulty Medical Devices
More than 1.7 million patient injuries and 83,000 deaths have been linked to defective medical equipment over a 10-year span.
HLM Mastermind
The FDA Calls Them 'Recalls,' Yet the Targeted Medical Devices Often Remain in Use
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of...
Innovation
An AI Cure for the Stuffy Nose?
The latest in digital therapeutics features a new device that uses Ai to scan a patient?s sinuses and create an...
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
HLM Mastermind
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.