Pink Sheet reporters and editors discuss the role of real world evidence in US FDA product decisions, staffing and other problems that are limiting the agency’s ability to implement lessons from the pandemic, and updates to COVID-19 vaccine adverse event reporting requirements.

Pink Sheet reporters and editors discuss the positive advisory committee recommendation for Amylyx’s proposed ALS treatment, the striking drop in clinical trials conducted in Russia following the start of the war in Ukraine, and questions about Medicare price negotiations avoiding political influence.

FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’

Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.