House Committee Releases 21st Century Cures Discussion Document – On January 27, 2015, the U.S. House of Representatives Energy and Commerce Committee released a discussion document as part of its 21st Century Cures initiative aimed at finding legislative solutions to help accelerate the discovery, development, and delivery of cures and medical advances in the United States. The draft bill contains provisions proposed by both Republicans and Democrats that, if endorsed and enacted, would (1) incorporate patient perspectives into the regulatory process and help address their unmet medical needs; (2) build the foundation for 21st century medicine; (3) streamline clinical trials; (4) support continued innovation at our federal public health agencies; and (5) modernize medical product regulation. The section-by-section summary of the discussion document is available here, and the Committee’s discussion document white paper is available here. All documents and additional background can be accessed on the Energy and Commerce Cures Website by clicking here.
Roundtable on ClinicalTrials.gov: Understanding the New Proposed Rule on Registration and Results Submission to the Publicly Accessible Data Bank – On February 17, 2015, King & Spalding will host a Roundtable Webinar to discuss the recent proposed rule issued by HHS that would expand the scope and requirements for registration and submission of clinical trial results, including adverse events, to the publicly accessible data bank, ClinicalTrials.gov. In addition, this program will address the new draft policy proposed by the National Institutes of Health (NIH) that would “piggy back” on the requirements and timelines in the proposed rule and set new requirements for public disclosure of results of all NIH-funded clinical trials. In this 90-minute session, K&S attorneys will share their experiences and discuss practical implications for healthcare providers, as well as drug and medical device manufacturers, engaged in clinical research. You do not have to be a client to attend, and there is no charge. You can register here to attend.
