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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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inconsistent analytical chemistry reports, and deficiencies in review of premarket submissions as a driver for the draft guidance. In Appendix A of the draft guidance, FDA provides suggestions on what is and is not considered “worst case” for the test articles used for testing.