Sue Sutter
Senior editor
USA
+22 year(s) experience
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.
Topic US-Shutdown fda
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
Scrip: 世界の医療用医薬品&製薬産業に関するニュース
FDA advisory committee's concerns about a mortality imbalance in Plivensia clinical trials would appear to reduce the odds.
Topic drug-review
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit.
Topic biosimilars
世界の薬事規制動向&情報を配信
10 Apr 2021
世界の薬事規制動向&情報を配信
01 Apr 2021
世界の薬事規制動向&情報を配信
11 Mar 2021
世界の薬事規制動向&情報を配信
04 Mar 2021
世界の薬事規制動向&情報を配信
28 Feb 2021
世界の薬事規制動向&情報を配信
25 Feb 2021
世界の薬事規制動向&情報を配信
25 Feb 2021
世界の薬事規制動向&情報を配信
25 Feb 2021
世界の薬事規制動向&情報を配信
24 Feb 2021
世界の薬事規制動向&情報を配信
23 Feb 2021
世界の薬事規制動向&情報を配信
08 Feb 2021
世界の薬事規制動向&情報を配信
28 Jan 2021
世界の薬事規制動向&情報を配信
26 Jan 2021
Pink Sheet: 世界の薬事規制と...
20 Dec 2020
Pink Sheet: 世界の薬事規制と...
10 Dec 2020