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Scott S. Liebman’s articles from Sheppard, Mullin, Richter & Hampton LLP are most popular:
with Senior Company Executives and HR
with readers working within the Pharmaceuticals & BioTech industries
On April 2, the FDA issued a warning letter to Agena Bioscience
Inc., alleging its product, intended for research use only (RUO),
was promoted for clinical purposes and thus violated the Food,
Drug, and Cosmetic Act.
In the article "FDA Warning Letter Tightens Reins On
'Research Only' Labels," published in Law360,
Sheppard Mullin FDA Regulatory attorneys Scott Liebman, Dominick
DiSabatino and Audrey Mercer discuss the significance of FDA's
response to the matter, which indicates a broader initiative to
scrutinize diagnostic products previously outside the realm of
regulatory control.
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