Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.
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From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots
Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.
Reference Pricing Clauses In US COVID-19 Contracts Leave Drug Industry Vulnerable
Innovation and price controls can coexist in the United States, COVID-19 contracts show. But drug pricing experts also acknowledge the unique circumstances of COVID-19 could make such contracts hard to replicate and argue that reference-pricing strategies may have limited ability to lower prices.
Woodcock To Be Acting US FDA Commissioner; Sharfstein Tops Biden's List Of Candidates For Post
Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.