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Scott Lassman: Waiving the Single Shared REMS Requirement
Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains the burden to the health system when FDA waives a single shared REMS requirement.
Transcript:
When the FDA waives the requirement of a single shared REMS system, what additional burden does that waiver place on the FDA?
A waiver of a REMS doesn’t really add a burden to the FDA. There may be a small burden because they’ve got to review and approve 2 different REMS, but the work it takes to help companies agree to a single shared REMS I think is at least as burdensome for FDA as reviewing and approving 2 REMS. I think where the real burden lies, and this is where FDA’s main concern is, is on the healthcare system. For instance, pharmacies and hospitals, they may get used to brands REMS and then all of a sudden, a generic is approved and if it has its own REMS, now you’ve got 2 different REMS that you’ve got to try and juggle. I think pharmacies don’t like it, physicians don’t like it, hospitals don’t like it, and I think that’s where FDA’s real concern is and why they’ve been so hesitant in a lot of cases to waive the single shared REMS requirement.
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Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
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IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
