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Strategy 6: Citizen Petitions and REMS Programs Risk Evaluation and Mitigation Strategies (REMS) are FDA-required safety programs for drugs with significant safety concerns
Clinicians should inform families that the evidence base for sermorelin in this age group is narrower than for rhGH, which has decades of large registry data
Some companies recognized the shift early and adapted
The ultimate goal is to transition from theoretical risks based on animal data to communicable risk intervals based on population data, providing a quantifiable basis for periconception risk counseling
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