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Q14 Analytical Procedure Development. FDA Guidance Document

The next step would be ruling out the compressive etiologies by gadolinium-enhanced MRI and, after structural abnormality investigation, cerebrospinal fluid (CSF) analysis for inflammation and defining demyelinating extension

and 3 are products referred to as skin substitutes, which were removed because we anticipate making changes to coding and payment policies regarding those products in future rulemaking