Oncology and Regenerative Medicine Products, and the Biden Administration
(Thursday, January 21, 2021)
The oncology products and regenerative medicine products in development should see major positive changes with the new administration. The cancer moonshot that was announced near the end of the Obama administration, has not been in much news for the last 4 years. President Biden has a long history of championing cancer therapy development, and it would be safe to assume that now that he is in-charge, there should be renewed support to oncology programs both at the NIH and FDA. Oncology products have seen enormous progress over the last decade with majority of the new products approved by FDA for such products, but cancer is still the second leading cause for death in the US. We should expect new or renewed programs, additional public funding, and regulatory support. Similarly, regenerative medicine was a key component of the 21st Century Cures Act passed in Dec 2016, but four years hence, there has been little changes in the profile of these products. Regenerative products, along with gene therapy products, hold the greatest promise for new innovative therapeutics. FDA is expected to announce major initiatives to regulate illegal regenerative therapy clinics in the country, and measures to encourage product development in this space. Of course, all of those would happen once the pandemic is behind us, which is expected in the next few months. So, keep an eye for announcements from the administration for these two product categories.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
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