My Op Ed in the with Mark McClellan on how FDA can enable a staged market entry of a safe and effective Covid vaccine, using an authorization for emergency use, to address those patients who can derive the most benefit from a safe product.
You can, but should you? I respectfully but vehemently disagree w/ & Mark McClellan's support of an emergency vaccine approval Their new starts w/ assertion of FDA trust, despite flagrant evidence to the contrary
My Op Ed on Covid vaccines. While authorization for emergency use may be optimal path to enable staged entry of safe and effective vaccine; we shouldn’t expect broad initial availability or accept regulatory bar any different than FDA’s gold standard.
Informative op-ed on vaccine EUAs from and Mark McClellan, but I still have questions about the process. Namely, how would an EUA impact our ability to collect the additional data we need to support broader use of a vaccine? 1/4
With Emergency Use Authorization, the FDA can approve a promising vaccine candidate for those most at risk while continuing to collect data, write and
My Op Ed in “How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine.” FDA should maintain the same gold standard for safety and efficacy of vaccine under EUA as under regular approval. EUA however gives agency lot of latitude to enable a staged entry.
How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine - WSJ
Through FDA's emergency use authorization, the agency can approve a promising candidate for those most at risk while continuing to collect data, write and Mark McClellan. Read their op-ed in