Katrina’s Blog™

The FDA has issued several revised guidance documents this month to support the updated 510k premarket notification pathway for devices which are modified versions of already approved devices. Readers will recall the 510k review is a determination that a new device is...

I mentioned CDERs Critical Path Innovation Meeting program in a previous post on pharmacogenomics as a venue for non-regulatory meetings on a wide variety of topics. The meetings are requested by external stakeholders who wish to hold collaborative discussions about...

Sponsored by the Product Quality Research Institute (PQRI)Pharmaceutical quality practitioners may be interested in this upcoming October webinar on QbD sponsored by the Product Quality Research Institute, or PQRI. The most interesting sessions are the discussions of...

For many years now the FDA has made submission of pharmacogenomic data voluntary for most types of applications (here’s the pharmacogenomic submission guidance and its companion document, both issued in 2005). This guidance is on CDER’s update publication schedule for...

Pharmaceutical and regulatory science devotees will want to catch the 2019 FDA Science Forum on September 11-12 virtually and on the FDA’s White Oak Campus in Silver Spring, MD. Participants will enjoy posters and sessions on a wide range of topics, with many...