James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Health Care Daily Report, in “Backers of Stricter Lab Test Policies Disappointed with FDA Delay,” by Michael D. Williamson. (Read the full version – subscription required.)

Following is an excerpt:

However, that may be different this time, because LDT makers aren't currently regulated by the FDA, James A. Boiani, a life sciences attorney with Epstein Becker & Green PC in Washington, told Bloomberg BNA Nov. 21.

“I think it will take the next administration a little time, but I'm hoping they won't leave the draft guidance out there for the next several years and leave people guessing,” Boiani said. “I would expect most labs won't follow the draft guidances. I wouldn't follow them if I were lab company.”

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