Katrina’s Blog™

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...

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,...

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...

Data integrity is increasingly an area of focus during regulatory inspections across the GXP world and has been the subject of several guidance documents from the FDA, MHRA, and PIC/S. Review of inspectional observations suggests the industry is still struggling to...

At some point on your journey to an approved drug, biologic, or medical device, you (and any contract organizations you’ve hired to help you with nonclinical, GLP, and clinical studies as well as manufacturing) will be subject to inspection by the regulatory...