Advertisement
Editorial: 'Right to try' laws could impede medical progress

Editorial: 'Right to try' laws could impede medical progress

By Merrill Goozner  |  February 11, 2017

The Trump administration has thrown its weight behind giving patients the “right to try” experimental drugs outside clinical trials. While such laws purport to offer hope for the dying, they will actually slow medical progress.

FDA finds cybersecurity threats in St. Jude devices

By Maria Castellucci  |  January 09, 2017

The Food and Drug Administration says St. Jude Medical's Merlin@home Transmitter could be hacked by an unauthorized user, which could lead to rapid battery depletion and inappropriate pacing or shocks to a patient's cardiac device.

The 2016 Year in Review: Winners and losers

The 2016 Year in Review: Winners and losers

December 17, 2016

Turbulent times always produce winners and losers, and the 2016 elections, MACRA, the 21st Century Cures Act and the general pace of change in the healthcare industry created plenty. Here are just a few.

Controversial changes coming to FDA

By Adam Rubenfire and Shannon Muchmore  |  December 03, 2016

The 21st Century Cures Act, which overwhelmingly passed the House last week, opens new avenues for companies to win quicker FDA approval. It continues to draw fire from safety advocates and worried payers, who foot the bill for expensive new therapies.

21st Century Cures Act reboot keeps controversial changes for FDA

21st Century Cures Act reboot keeps controversial changes for FDA

By Adam Rubenfire and Shannon Muchmore  |  November 29, 2016

With the fast-tracked reboot of the 21st Century Cures Act, drug and device manufacturers may be about to win long-sought revisions to how the Food and Drug Administration approves and regulates their products.

Why can't devicemakers and insurers get along?

Why can't devicemakers and insurers get along?

By Adam Rubenfire  |  November 26, 2016

For patients who want to use newer, novel devices beyond clinical trials, affordability is often the central issue blocking access when insurers won't cover their purchase. Manufacturers that can't get widespread coverage for their products face the prospect of limited sales.

Trump picks 'A-team' for healthcare transition as ACA repeal looms

Trump picks 'A-team' for healthcare transition as ACA repeal looms

By Virgil Dickson  |  November 12, 2016

Sources say President-elect Donald Trump's transition team for HHS will be led by Andrew Bremberg, who worked at the agency under President George W. Bush and was an adviser to Senate Majority Leader Mitch McConnell and during Wisconsin Gov. Scott Walker's presidential bid.

Editorial: Drug marketing veers off-label

Editorial: Drug marketing veers off-label

By Merrill Goozner  |  November 05, 2016

The Food and Drug Administration is considering dramatic changes to its drug marketing rules that threaten to make the problem of already out-of-control drug spending even worse.

Advertisement