Tag Archives: #COVID-19 #coronavirus #pharma

Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2

Posted on March 26, 2020 by Mark Senak

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

Posted in Advisory Committee Prepapartion, Approval Announcements, Current Affairs, FDA Policy | Tagged , | 14 Comments

FDA Guidance on Clinical Trials During COVID-19 Pandemic

Posted on March 20, 2020 by Mark Senak

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

Posted in Clinical Trials, FDA Policy | Tagged | Comments Off on FDA Guidance on Clinical Trials During COVID-19 Pandemic