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Synthetic Origins

Codon

Hermann Bujard had done careful work analyzing the features of bacterial promoters that could allow them to be both strong and tightly regulated, two of the key properties necessary for the repressilator to work. It really fits perfectly, and it is analogous to chemistry, where you've got synthetic chemistry and analytical chemistry.

RNA 56
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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog: Biosimilars

FDA also notes variability in the approaches, inconsistent analytical chemistry reports, and deficiencies in review of premarket submissions as a driver for the draft guidance. By Adrienne R.