Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives
US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.
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Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Organizations like BARDA, CEPI and others are looking to partner with industry to rapidly test, manufacture, package and deploy vaccines and therapeutics, identifying areas they want to work together during BIO’s recent summit.
Eschewing the standard approval mechanisms for COVID-19 vaccines is likely only appropriate in very limited high-risk populations, unless clinical efficacy outcomes are available, former FDA leaders say.