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Taylor JR, Scott JE, Cribb AM, Bosworth TR

Concerns have been raised regarding the potential for abnormal cell growth, particularly in the absence of long-term safety data from clinical research

Long-Term Safety Considerations As a relatively new class of medications, the long-term safety profile of GLP-1 agonists is still under evaluation

The firm in its response described a cleanroom remodel , but the FDA found the supporting documentation insufficient: no specification documentation for ceiling tiles, no demonstration that materials are suitable for pharmaceutical use, no updated cleanroom certification, and no environmental monitoring data for the remodeled suite