Hannah Daniel
Senior Reporter
Latest From Hannah Daniel
Without Additional Funding, US FDA's Inspections In Jeopardy – Regulatory Affairs Chief
Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers.
ORA Chief Says Inspections In Jeopardy Without Additional Funding
The US FDA’s Office of Regulatory Affairs is facing challenges in retaining and hiring new staff, which will impact inspections, ORA chief Michael Rogers said.
Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement.
ORA’s Chief Says Without Additional Funding, Inspections Are In Jeopardy
Without additional funding from Congress, the FDA’s ORA is facing challenges in retaining and hiring new staff, which will impact inspections, said ORA’s chief Michael Rogers during a webinar.
News We’re Watching: Philips Settles Recall Fallout; FDA REdI, Townhalls, Approvals
This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.
Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden
Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”