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It has taken us, so far, one-third of the time to issue warning letters from the date that the inspection closes to the date of warning letter issuance. 16 The April 2025 reduction in force (RIF) at FDA does not appear to have impacted WLs for FY25

Any future GLP-1 patch formulations would need to demonstrate similar therapeutic benefits across these indications through rigorous clinical trials before receiving regulatory approval from the MHRA and EMA

Recent phase 2 and phase 3 clinical trials have established the therapeutic value of various GLP-1 RAs in improving liver histology and metabolic parameters in patients with MASH