Semaglutide, a weight-loss drug developed by Novo Nordisk , is currently in short supply due to high demand, leading some people to seek out "generic" or compounded versions of the drug instead, Sophie Putka reports for MedPage Today
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One might think this is the ideal situation for a pre-submission meeting with FDA, but in the world of medical device development where speed to market, regulatory milestones, and investment capital are critical to a companys success, the requirements and time involved in the FDA presubmission program can often make it a non-starter
These include: Its potential ineffectiveness Serious health complications Contamination risks The financial burden associated with ineffective treatments Additionally, the anxiety and stress related to using outdated medications can weigh heavily on your mind
Clemmons, et al