ZMapp Ebola Trial To Start ‘Any Day’ With New FDA/NIH Protocol
This article was originally published in The Pink Sheet Daily
Study design involves series of pairwise comparisons of novel interventions against optimized standard of care.
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FDA officials explain why randomized clinical trials of Ebola products are necessary and the Senate passes Ebola priority review voucher bill. Lilly/AstraZeneca start Alzeimer’s trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.
Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.