Therefore, we recommend that companies determine their regulatory pathway to market in 2025-2026 and consider pre-subs in 2026 to allow time to take action on any FDA feedback before submitting the premarket submission
If your child is not eating enough while on a GLP-1, the consequences can be low energy, dizziness, bloating, burping, constipation, nausea, and vomiting
Furthermore, as diarrhea and constipation are among the most frequently reported gastrointestinal AEs stemming from altered intestinal motility, their management should be expanded to include dietary fiber adjustments and targeted fluid repletion
For example, some plans limit prescriptions to a months supply at a time
This step-by-step method helps your body adjust and reduces early side effects