世界の薬事規制動向＆情報を配信
By nielsen-hobbs 29 Nov 2020
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
世界の薬事規制動向＆情報を配信
By nielsen-hobbs 27 Nov 2020
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
世界の薬事規制動向＆情報を配信
By nielsen-hobbs 02 Oct 2020
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.
世界の薬事規制動向＆情報を配信
By nielsen-hobbs 22 Sep 2020
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: 世界の医療用医薬品＆製薬産業に関するニュース
By nielsen-hobbs 03 Jun 2020
‘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
世界の薬事規制動向＆情報を配信
By nielsen-hobbs 30 Aug 2018
"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
Scrip: 世界の医療用医薬品＆製薬産...
09 Dec 2015
