Partners Jacqueline Berman and Maarika Kimbrell wrote an article for Law360 summarizing draft guidance from the US Food and Drug Administration that revises its approach to the dissemination of scientific information on unapproved uses (SIUU) of approved or cleared medical products. In the article, Jaqueline and Maarika also offer key takeaways from the draft guidance.
According to the article, “[o]n the whole, the new draft SIUU guidance would provide some necessary clarity with respect to the communication of scientific information regarding unapproved uses of approved products, providing companies with greater certainty on the scope of scientific information that may be disseminated, as well as how such information may be communicated to the medical community.”