Category Archives: Clinical trials regulatory aspects of digital pathology

Issues and regulations related to the use of digital pathology and whole slide imaging in pharmaceutical human clinical trials

FDA’s Proposed Policy in Companion Diagnostics

On July 12, 2011, the FDA released a new draft guidance on the development and review of companion diagnostics (CDx). I would encourage anyone working in anatomic pathology to review the draft, as it will have widespread impact on digital pathology companies, antibody providers, and anatomic pathologists in both private practices and large reference laboratories. The [...]

Scratching the surface of quantitative dermatopathology

Quantitative dermatopathology is just scratching the surface with digital pathology

Radiology versus pathology: Not more quantitative, just more digital

At a molecular imaging meeting earlier this year, Flagship presented pharma regulatory compliance for digital pathology. Our talk was the only one on pathology. The others were all various presentations on the different modalities of radiology imaging applied to clinical trials — X-ray, MRIs, microCT scans, PET scans, CAT scans, dog scans, and so on A [...]