Regulatory/Legislative News

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.

Physicians demonstrated limited understanding of the FDA approval process and the meaning of the “breakthrough therapy” designation, according to recent research in JAMA.

At OSN New York, Allison W. Shuren, MSN, JD, and Candace S. Simerson, COE, CMPE, discuss legal, regulatory and payment topics relevant in ophthalmology.

The U.S. Senate is considering a bipartisan bill intended to speed up the development of genetically targeted drugs for patients with rare life-threatening or debilitating conditions.

The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported legislation that would streamline the FDA’s evaluation process for medical devices, one of seven biomedical innovation bills currently advancing to the full Senate for consideration.

In a recent session, the Senate Committee on Health, Education, Labor and Pensions favorably reported a bill requiring manufacturers of reusable medical devices to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also would require the FDA to develop guidance on when manufacturers should seek clearance from the agency before marketing their products.

The Senate Health Committee passed the “Advancing Research for Neurological Diseases Act of 2015” (S. 849)” on Tuesday, which will establish a national surveillance system for neurological diseases. The full Senate will now consider the bill.

The Senate health committee passed the Next Generation Researchers Act (S. 2014) with bipartisan support on Tuesday, which aims to increase opportunities for young researchers and attract them to the NIH. The full Senate will now consider the bill.

The U.S. Senate Committee on Health, Education, Labor and Pensions unanimously recommended a measure designed to improve health care information technology.

To the Editor: