Regulatory/Legislative News

So far in 2015, four different ophthalmic products in phase 3 clinical trials failed to meet their primary endpoints. Ocular Surgery News spoke with three of these companies to find out what happened and how they responded. Their stories offer a telling glimpse at the challenges and opportunities companies face when endpoints are missed in clinical trials as part of the overall innovation cycle.

In agreement with the FDA’s recent draft guidance on nonproprietary naming of biological products, six physician groups collectively sent a letter to CMS Acting Administrator Andrew Slavitt on Tuesday urging CMS to adopt unique billing codes for biosimilars, according to a press release.

The FDA today announced the availability of a draft guidance describing its proposal on the nonproprietary naming of biological products.

Due to expanded health insurance coverage from the ACA, as well as the aging population and economic growth, health care spending is projected to increase at a rate of 5.8% annually between 2014 and 2024, according to recently published data in Health Affairs. 

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

By a vote of 344 to 77, the U.S. House of Representatives on July 10 passed the 21st Century Cures Act, a bipartisan bill that authorizes several changes to the approval process for drugs and medical devices.

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.