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Synthetic Origins

Codon

It really fits perfectly, and it is analogous to chemistry, where you've got synthetic chemistry and analytical chemistry. Asimov Press (2024). And do you feel like the field has reached an inflection point now, where a lot of the hype you initially worried about is now becoming real? Cite: Michael Elowitz.

RNA 57
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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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inconsistent analytical chemistry reports, and deficiencies in review of premarket submissions as a driver for the draft guidance. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).