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Vigorous shaking creates mechanical stress that promotes aggregation, the clumping of peptide molecules that reduces potency

Although the relative quiet since March might have suggested a shift in enforcement direction, the emerging pattern is that FDA conducts ongoing monitoring and then releases warning letters in coordinated batches rather than steadily over timemeaning quiet periods should not be read as reduced priority

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6.5.2 Oral semaglutide in established T2D (mean disease duration: 79 years) In patients with T2D uncontrolled on metformin (PIONEER 2), oral semaglutide (14 mg) provided significantly greater reductions in HbA 1c versus empagliflozin (25 mg) at Week 26 (1.3% vs 0.9%