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...
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Critical Path Innovation Meetings
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...
Webinar on QbD
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...
Pharmacogenomics at the FDA
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...
The 2019 FDA Science Forum
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...
Pharmaceutical Quality Symposium in October
October is shaping up to be an excellent month for Public discussions sponsored by the FDA. The latest to be announced is a SBIR symposium on pharmaceutical product quality to be held in College Park, MD on October 16-17. The agenda covers the agencies practices for...
Workshop on RWE in Early October
IIn a previous post, I discussed the FDAs publication of a framework for Real World Evidence (RWE) last December, and we’ve looked at its use in drug and device submissions since then. The agency, in cooperation with the Duke Margolis Center for Public Health Policy,...
Updates to the Q&A Guidance on Laboratory Controls
On August 12, 2019, the FDA updated its guidance Question and Answers on Current Good Manufacturing Practices – Laboratory Controls to add 3 new questions with answers focused on laboratory tests using chromatographic systems. This level 2 guidance presents a list of...