An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
-- 10,000 participant randomized Phase 2b study will evaluate Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate containing Spike plus other viral targets with an approved vaccine against ...
Under the new draft guidance, FDA will no longer routinely require data from comparative clinical efficacy studies to support a demonstration of biosimilarity for therapeutic protein products.
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