Hogan Lovells is always thinking about how to conquer and foresee the most significant industry issues facing our clients. If you’ve been following us for the past two years, you’ve heard first-hand from our lawyers around the world on significant developments in the Life Sciences & Health Care sector and why they are so passionate about the industry. In season 3, we’ll unpack new and exciting industry trends and bring you more outside perspectives to keep you ahead of the curve.
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Hogan Lovells is always thinking about how to conquer and foresee the most significant industry issues facing our clients. If you’ve been following us for the past two years, you’ve heard first-hand from our lawyers around the world on significant developments in the Life Sciences & Health Care sector and why they are so passionate about the industry. In season 3, we’ll unpack new and exciting industry trends and bring you more outside perspectives to keep you ahead of the curve.
Pharma – The Last Word – Regulatory and legal trends in the pharma and biotech industries
Talking the Cure by Hogan Lovells
13 minutes
1 year ago
Pharma – The Last Word – Regulatory and legal trends in the pharma and biotech industries
In this episode of ”Pharma - The last word,” host Phil Katz, discusses regulatory and legal trends in the pharma and biotech industries with Komal Karnik Nigam. They delve into the FDA’s evolving approach to data packages required for drug approval, highlighting the increased flexibility in accepting alternative forms of evidence. Komal explains how FDA’s guidance has shifted from demanding large, multicenter trials to considering confirmatory evidence such as natural history studies, mechanistic data, and data from other products in the same class. The episode emphasizes the importance of strategic planning and early consideration of data presentation in regulatory interactions.
Talking the Cure by Hogan Lovells
Hogan Lovells is always thinking about how to conquer and foresee the most significant industry issues facing our clients. If you’ve been following us for the past two years, you’ve heard first-hand from our lawyers around the world on significant developments in the Life Sciences & Health Care sector and why they are so passionate about the industry. In season 3, we’ll unpack new and exciting industry trends and bring you more outside perspectives to keep you ahead of the curve.
