In an article published on Jan. 1, Clinical Laboratory News interviewed Nelson Mullins partner Christopher Hanson about a recent proposed rulemaking issued by the U.S. Food and Drug Administration (FDA) concerning laboratory developed tests (LDTs). Hanson chairs the firm’s FDA Regulatory Compliance & Litigation practice group and regularly represents in vitro diagnostic (IVD) manufacturers as well as clinical laboratories.

"I think the FDA proposed this rule because it was frustrated with the lack of action that Congress has taken to implement comprehensive diagnostics reform," Hanson told Clinical Laboratory News. "There has been a clear push for five or six years to come to a resolution about how LDTs and conventional IVD test kits can be regulated under the same framework. I think this was the FDA’s last resort."

Read the full article here.