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Substantial equivalence: Eclipse and Glo – same difference?

Written by || 1st March 2018 || Regulatory reports , Topic regulatory reports || FDA | Regulation and Legislation | North America United States

BAT has chosen to seek market authorisation in the US for its heat-not-burn product Glo on the basis of its “substantial equivalence” to a previous product, Eclipse – but what are the pitfalls and the advantages in this approach? ...

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