PV & RA division of SPER Market Research
Article 1
Ensuring Compliance and Patient Safety
The Investigational New Drug (IND) application is a crucial step in the drug development process. To ensure patient safety and maintain regulatory compliance, the U.S. Food and Drug Administration (FDA) requires sponsors to submit IND safety reports for any serious and unexpected adverse events linked to their investigational product.
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IND safety reporting helps pharmaceutical and biotech companies monitor potential risks and take timely action to mitigate them. However, navigating the FDA’s complex safety reporting guidelines can be challenging, which is why partnering with experts like Viginovix can streamline this critical process.
Article 2
Establishing a Signal Management Process
Generic pharmaceutical companies operate in an increasingly complex and competitive market. While developing generic medications is often faster and more cost-effective than innovator drug development, post-marketing safety and signal management remain critical to maintaining product integrity and public trust. Without a well-structured process to detect and respond to potential safety issues, even established generic drugs can face regulatory scrutiny and patient safety risks.
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This article explores the key components of a signal management process tailored for the unique environment of generic manufacturers and highlights how Viginovix can help enhance these activities.