FDA Law Blog
MAY 3, 2021
The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.
FDA Law Blog
MAY 3, 2021
The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.
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XTalks
APRIL 26, 2021
Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa.
Delveinsight
AUGUST 12, 2021
LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome. Visus is yet to deliver phase 2 data but has a potentially differentiated asset.
Placebo Control
JULY 31, 2013
Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant.
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