Ashley Yeo
Healthcare Editor
UK
+21 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
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated
Topic Vaccines Coronavirus Distribution
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
Topic Coronavirus vaccines
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
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
Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.
Topic fda
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.
Topic biosimilars
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
US FDA officials say they need knowledge of the disease to have the confidence to use accelerated approval.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing.
Topic Biosimilars
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
House bill that would require new clinical studies from sponsor for tropical disease priority review vouchers met with industry concerns about limiting the US agency's flexibility.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.
Topic drug-review
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