Evidence Accelerator: Diagnostics Lab Meeting

This month's Diagnostics Lab meeting we will look at LAMP-based diagnostics; Testing in the airline industry and air travel. We will hear presentations from Dr. Nilay Shah of Delta Airlines and Randy True of FloodLamp Biotechnologies.

This is the once-monthly COVID-19 Evidence Accelerator Diagnostics Lab Meeting. These meetings occur the third Thursday of every month at 12 pm ET. 

If you are interested in attending the meeting series please email  evidenceaccelerator@reaganudall.org.

Naloxone Access: Answering Questions

What: The Reagan-Udall Foundation for the FDA (FDA Foundation), in collaboration with the U.S. Food and Drug Administration, is hosting a virtual public meeting to explore questions about access to naloxone, a drug used to reverse opioid overdoses. Harm reduction specialists, physicians, pharmacists, and regulators will share their experiences in addressing the availability of this life-saving medication for heroin, fentanyl, and prescription opioid overdose. Significant time is set aside to allow public comment for up to 30 people (pre-registration required).

US FDA Tries To Shape The Accelerated Approval Reform Narrative - Pink Sheet

US Food and Drug Administration officials appear to want stakeholders, and maybe more importantly, lawmakers, to let go of the notion that failure is not an option with accelerated approval.

“There is going to be uncertainty regarding whether the drug will actually impact a clinical outcome at the time of approval,” Jacqueline Corrigan-Curay, FDA Center for Drug Evaluation and Research principal deputy center director, said during an 11 March Reagan-Udall Foundation webinar on the expedited pathway. “Uncertainty by definition means that not every study will confirm benefit.”