FDA / clinical trial Exposure to NDMA after taking ranitidine

@kpcross @AndyTeasdale recent regulatory highlight has been very well received by the community. Several discussion threads related to topics raised there.

Regulatory Highlights(OPR&D)

The Ranitidine worked referenced Searle et all demonstrated that NDMA is formed because of an intermolecular degradation reaction in solid-state. What is fascinating to me is the link between NDMA rate of formation and the crystal morphology, with columnar crystals exhibiting the slowest rate of formation.

https://doi.org/10.1021/acs.oprd.0c00462