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CMS to form inter-agency group to review Stark law The CMS plans to convene an inter-agency group to figure out how to minimize the regulatory barriers of federal anti-kickback laws, which have slowed providers’ move to value-based care, according to CMS Administrator Seema Verma. The CMS, HHS’ Office of Inspector General, HHS’ General Counsel and the Department of Justice will participate in the group. The ... Read More
GAO: Medicare’s Opioid Use Monitoring Lets At-Risk Patients Fall Through the Cracks Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house ... Read More
Whistleblower Says Drugmaker Fired Him for Raising Concerns About CMO A newly unsealed whistleblower lawsuit claims Regeneron fired a manager for raising concerns about the drugmaker’s manufacturing process. In the lawsuit, filed in October in the Southern District of New York, Stanley Koshy claimed he was ignored when he raised concerns about testing practices at one of the laboratories Regeneron contracted for manufacturing. Koshy claimed he raised ... Read More
Conflict of interest concerns keep CDC's Fitzgerald away from yet another meeting with Congress A Senate health committee held the first of two hearings Wednesday over the current state of the nation’s readiness to address public health emergencies, which led to calls to improve the reliability of data collected during and after disasters. But before senators could tackle some of those pressing issues, they first had to contend with the ... Read More
The Case for Intelligent Design (and Infrastructure) in Life Science Biologics R&D New White Paper from IDC Health Insights examines industry trends, new challenges and emerging capabilities in biologics. With many recent blockbuster patents expiring, the pharmaceutical industry finds itself in the middle of a transformation. Leading life science organizations are updating their business strategies to include the pursuit of a new market opportunity – the discovery and development ... Read More
01/16/2018 - 01/18/2018
|7th Trial Master File Summit|