Latest From Bowman Cox
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.
Not all technology platforms provide the expected benefit of filling in CMC review gaps and speeding coronavirus vaccine approvals.
US, EU and Canadian authorities recently discussed their approaches to rolling reviews of CMC applications for coronavirus vaccines.
US FDA suggests meeting with investigators onsite by video instead of in person, moving document rooms outside, avoiding paper and more. UK MHRA shares similar recommendations.
US government stockpiles more drugs, refines pandemic surveillance with wastewater sampling and more as it braces for winter.
By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.