News That Quotes Us & Our Work Archives

Cur is Crowdfunding a Medical Device That isn’t Cleared by the FDA, and That’s a Problem

The Verge, May 14, 2015. A company called Cur is developing a promising new pain-relieving product, according to Mashable, Fast Company, and PC World. Problem is, the company is doing it by launching a $50,000 crowdfunding campaign on its own website prior to filing for the necessary FDA clearance. The move could doom the product before it ever hits the market — or it could point to a glaring loophole in FDA regulations.

Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

The New York Times, May 3, 2015. When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes.

Bill to Speed Approvals for Drugs Is Cut Back

The New York Times, April 30, 2015. Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.

Diet Drug Companies Spent $60 Million Since 2010 Amid Push to Win FDA Approval for New Products

Journal Sentinel, April 19, 2015. In the months before the U.S. Food and Drug Administration did an about-face on diet drugs, agency officials participated in a series of meetings at George Washington University.

What Do Stakeholders Think Of FDA’s Latest Effort To Get Patients Timelier Access To Devices?

Bloomberg BNA, April 10, 2015. The FDA released two final guidance documents that will provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs…however, not everyone is pleased with the guidance.