This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in both regions.
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Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
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In the Part 1 of the blog post, we explored the regulations relating to medical devices and cosmetic products in…
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Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
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In the competitive race for innovation and marketing, a manufacturer may develop new technological products with the objective of using…
