Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2023-06-20 09:26:422025-09-26 15:58:56U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Meenakshi Dattahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeenakshi Datta2023-06-08 14:01:322025-09-26 15:59:26Five Tips for Bringing a Complex Digital Health Product to Market
The U.S. government has expressed concern over misleading marketing by some Medicare Advantage and Part D plans. Now, a much wider range of marketing materials will need to be approved by the government prior to distribution. Jon Zucker and Taylor Andelman explain the changes.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2023/05/Telehealth-2.jpg606833Jon S. Zuckerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJon S. Zucker2023-05-26 09:28:122025-09-26 15:59:52CMS Now Needs to Approve Medicare Ads That Mention Plan Benefits
The U.S. has issued final guidance on clinical decision support (CDS) software but, in the EU, the treatment is less nuanced and needs clarifying. Ioana Ratescu of Novartis and Eva von Mühlenen, Deeona Gaskin, and Zina Chatzidimitriadou of Sidley explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Eva von Mühlenenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEva von Mühlenen2023-05-25 09:02:392025-09-26 16:00:14Clinical Decision Support Software Approach Updated in the U.S. but Still Confused in Europe
The U.S. Inflation Reduction Act (IRA) is reshaping the commercial landscape for drug development, with smaller biotechs and investors in particular thinking hard about how to adapt to the new environment. Meena Datta explains the challenges posed to the biopharma industry by the IRA.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Meenakshi Dattahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeenakshi Datta2023-05-23 09:08:292025-09-26 16:00:41Impact Of Inflation Reduction Act On Drug Development For U.S. Market
The UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology appraisals and highly specialised technologies, the decisions of which are crucial to the life sciences industry. Maria Isabel Manley and Victoria Kerr explain the changes.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-07.png606833Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2023-05-19 11:15:522025-09-26 16:01:14New Guidance on Appeals Against UK Health Tech Appraisals Applies From June
The European Parliament’s provisional agreement on the EU’s AI Act encompasses generative AI and imposes the requirements that are applicable to high-risk AI systems onto general purpose AI. As negotiations continue, Josefine Sommer, Eva von Mühlenen and Zina Chatzidimitriadou explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2023-05-18 09:11:302025-09-26 16:01:42European Parliament’s Position on the AI Act Moots Significant Changes
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U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Yuzhi Hu
Five Tips for Bringing a Complex Digital Health Product to Market
Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.
Meenakshi Datta
Chicago
mdatta@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
CMS Now Needs to Approve Medicare Ads That Mention Plan Benefits
The U.S. government has expressed concern over misleading marketing by some Medicare Advantage and Part D plans. Now, a much wider range of marketing materials will need to be approved by the government prior to distribution. Jon Zucker and Taylor Andelman explain the changes.
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Taylor Andelman
Washington, D.C.
tandelman@sidley.com
Clinical Decision Support Software Approach Updated in the U.S. but Still Confused in Europe
The U.S. has issued final guidance on clinical decision support (CDS) software but, in the EU, the treatment is less nuanced and needs clarifying. Ioana Ratescu of Novartis and Eva von Mühlenen, Deeona Gaskin, and Zina Chatzidimitriadou of Sidley explain.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Impact Of Inflation Reduction Act On Drug Development For U.S. Market
The U.S. Inflation Reduction Act (IRA) is reshaping the commercial landscape for drug development, with smaller biotechs and investors in particular thinking hard about how to adapt to the new environment. Meena Datta explains the challenges posed to the biopharma industry by the IRA.
Meenakshi Datta
Chicago
mdatta@sidley.com
New Guidance on Appeals Against UK Health Tech Appraisals Applies From June
The UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology appraisals and highly specialised technologies, the decisions of which are crucial to the life sciences industry. Maria Isabel Manley and Victoria Kerr explain the changes.
Maria Isabel Manley
London
mmanley@sidley.com
Victoria Kerr
London
vkerr@sidley.com
European Parliament’s Position on the AI Act Moots Significant Changes
The European Parliament’s provisional agreement on the EU’s AI Act encompasses generative AI and imposes the requirements that are applicable to high-risk AI systems onto general purpose AI. As negotiations continue, Josefine Sommer, Eva von Mühlenen and Zina Chatzidimitriadou explain.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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Biotech Dealmaking – Regulatory Considerations for the Next Wave of Development-Stage Transactions – Program and Lunch
Connecting Clusters of Excellence: Europe as Your Gateway to Global Success
At the Table: Serving Up a Lively Discussion With the FDA and USDA
Life Sciences College 2026
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