The FDA has not defined the term skin substitute. However, the term has been used as a descriptor for certain wound care constructs that are currently approved under a BLA or PMA for treatment of burns or skin ulcers, including ulcers that appear to have failed to heal after standard of care
We proposed to specify the proposed approach in amendments to the Shared Savings Program regulations at new 425.605(i) (BASIC track) and new 425.610(l) (ENHANCED track)
Sikiric P, Seiwerth S, Grabarevic Z, Petek M, Rucman R, Turkovic B, et al
Monitoring schedule Healthcare providers who specialize in GLP-1 therapy typically recommend this monitoring cadence: Baseline: Full B12 panel before starting semaglutide 3 months: Repeat serum B12 and MMA 6 months: Full panel reassessment Annually: Once stable, annual monitoring is usually sufficient For high-risk patients (metformin users, vegans, those over 60, post-bariatric surgery), the 3-month check is particularly important