COVID-19 is impacting the healthcare system in a way we’ve never seen before, and pharmaceutical manufacturers are facing new challenges at rapid speeds. To help keep you informed, we’re releasing a special Q&A series with our experts to discuss the virus’s impact on each stage of the launch journey.
Today, we spoke with DSCSA and Serialization Services Manager Michael Rowe about the effect of COVID-19 on the DSCSA regulatory timeline.
In short, it isn’t. While the FDA may temporarily be tied up in other work and may pause on site verification visits, manufacturers should still count on having to report as usual.