Commissioner Hahn says FDA will see data as it is compiled to speed review; enrollment criteria raises some eyebrows since Moderna plans to exclude patients with known history of SARS-CoV-2 infection from Phase III. The agency’s guidance on COVID-19 vaccine trials says that such exclusions are not necessary since screening is unlikely when a product would be delivered post-market.
Assessors at the US Food and Drug Administration will see the Phase III and other data on Moderna, Inc.’s coronavirus vaccine candidate before application submission in order to ensure an approval decision can be made as soon as possible.
FDA Commissioner Stephen Hahn said on 27 July that the agency would employ its real-time assessment mechanism for the candidate,...
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
