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!
Your Company’s First IND: READY, SET, GO!
View our complimentary 30 minute webinar from the comfort of your own desk. Dr. Lisa Jenkins VanLuvanee will share her valuable insights and practical experiences with regard to preparing for your first IND. In this presentation, Dr. VanLuvanee will address the following questions:
- What is an IND and how should I plan for it?
- What is required for an IND?
- How do I build my first IND?
If you have an IND in your future, join us for this webinar so you and your team will be well-equipped to cross the finish line in record time!