DEVELOPMENT EXPERTISE AND SOFTWARE TO GET YOU TO AND THROUGH THE FDA
The results of successful R&D efforts in the life sciences industry are a broad set of complex documentation that tells a story about a drug or product. This documentation requires scientific, development, and regulatory expertise to clearly articulate the product potential while executing on the development strategy.
WHY FACET LIFE SCIENCES
Facet Life Sciences supports your development goals with expert development services. We help you to create the strategy, execute the plan, author, store and manage evolving R&D documentation and protect your valuable research assets as you move toward your next development milestone.
Current Events
Are You a Drug or Device?
Unseen Regulatory and Intellectual Property Impact of Genus
Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the Genus decision, FDA intends to regulate products that meet both drug and device definition as medical devices, except where the statute indicates that Congress intended a different classification.
What’s more, FDA also plans to review all FDA-approved imaging agents and potentially reclassify them as drugs or devices according to whether they achieve their primary intended purpose through chemical action or are dependent on being metabolized for the achievement of their primary intended purpose. This means that some currently approved imaging agents regulated as drugs will transition to be regulated as medical devices!
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