Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Getting a new lab space? Design it for safety now and save thousands later
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Let me tell you a story. Once upon a time, there was a laboratory manager who worked in a hospital that was designing a new stand-alone emergency department building which would include a…
Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers
From - G2 Compliance Advisor
The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
The big story of April wasn't any particular new deal but the apparent resolution of an old one—the Abbott-Alere merger. Deal volume remained…
FDA Sends 14 Warning Letters Regarding Cancer Products
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to…
5 ways to end generational stereotyping in your lab
By Dr. William A. Schiemann bio
These days, the Millennial Generation is hyped, perhaps even more than Baby Boomers were hyped in the 1950s and 1960s. As I meet with executives around the globe, there is widespread confusion and…