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Executive Editor, Policy and Regulation
+26 year(s) experience
Pink Sheet
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Topic Coronavirus FDA
Pink Sheet
The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?
Topic FDA
Pink Sheet
Trump and Biden trade barbs in debate that included a suggestion by the president that coronavirus vaccine development delays are political and saw Biden questioned on whether he was contributing to vaccine hesitancy.
Pink Sheet
A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.
Topic US Election 2020 FDA
Scrip
‘What we have to guard against is that when the streets quiet down … a lot of people are going to go back to their normal lives,’ Merck CEO Ken Frazier says in an interview with CNBC.
Topic Leadership
Pink Sheet
"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."
Topic FDA
Pink Sheet
25 Oct 2016
Scrip
09 Dec 2015
