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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.

Where Clinton and Trump stand on healthcare policy

Where Clinton and Trump stand on healthcare policy

By Harris Meyer  |  November 07, 2016

Today's elections surely won't end the eight-year political war over the shape of the U.S. healthcare system. But the ballot results likely will determine whether the changes driven by the ACA continue in the same direction or the system returns to its previous, less-regulated form.

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.

Innovations: Integrating diabetic eye screenings with primary care

Innovations: Integrating diabetic eye screenings with primary care

By Erica Teichert  |  October 29, 2016

A company called Intelligent Retinal Imaging Systems, or IRIS, has developed a cloud-based platform and image-enhancement technology that connects primary-care physicians with optometrists and ophthalmologists who can read eye exam images taken during a normal doctor visit.

Blog: Does the FDA enable drugmakers to jack up prices on cheap old drugs?

Blog: Does the FDA enable drugmakers to jack up prices on cheap old drugs?

By Harris Meyer  |  October 17, 2016

There are many reasons for the nation's rising prescription drug spending, which increased 6.3% from August 2015 to August 2016. But you wouldn't think one of them would be that the federal government is actively encouraging drug companies to slap higher price tags on old, cheap products.

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