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Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK
Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
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The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization
Following the UK’s departure from the EU In 2021, the MHRA has introduced several initiatives to foster product development and…
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Best ePRO practices – A patient centric approach
The adoption of Electronic Patient-Reported Outcomes (ePRO) in clinical research marks a significant evolution in the way patient-centered data is…
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Q&A regarding common concerns of China’s NMPA (National Medical Products Administration)
The rapid development of China’s pharmaceutical market has attracted the attention of many international health–tech companies. China has a huge…
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Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…
In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
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Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU
Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
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The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the Part 1 of the blog post, we explored the regulations relating to medical devices and cosmetic products in…
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FDA Meeting Series: How, When and What – INTERACT Meetings
INTERACT Meetings What: CDER is now also accepting INTERACT Meetings. Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT)…
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