Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.
FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?
Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Olivier Goarnisson
Francesca Blythe
London
fblythe@sidley.com
Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. Read more
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
How to Guard Against Biologics and Medtech Patents Litigation
Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Ching-Lee Fukuda
New York
clfukuda@sidley.com
Why Venture Capital Investors Are Focused on Femtech
Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.
The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Francesca Blythe
London
fblythe@sidley.com
Andrew Harper
If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
China’s first dedicated law on personal data protection comes into effect this month. Sidley counsel Jing Lu looks at how the new Personal Information Protection Law (PIPL) differs from Europe’s General Data Protection Regulation (GDPR).
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Chen Yang
Sydney, Hong Kong
cyang@sidley.com
U.S. Looks to Introduce European-Style Drug Price Controls
Meena Datta examines proposed new legislation that would authorise the Health and Human Services Secretary to negotiate prices directly with prescription drug manufacturers.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Meenakshi Datta
Chicago
mdatta@sidley.com
Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions
Becky Wood in Washington, D.C., Emily Marden in Palo Alto, and Josefine Sommer in Brussels look at new FDA guidance on the use of real-world data to support new indications and post-approval study requirements.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims
Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Jonathan Tomlin
London
jtomlin@sidley.com
Elizabeth C. Curtin
What Do the FDA’s Expanded ‘Intended Use’ Regulations Mean for Safe-harbored Communications about New Uses?
Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.
FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.
Read more
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Coleen Klasmeier
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Pharmacovigilance Considerations in the Era of Patient Centricity: Data Collected by Apps
On World Patient Safety Day, Torrey Cope in Washington, D.C., Chen Yang in Beijing, and Olivier Goarnisson in Geneva consider one big pharmacovigilance question raised by the increasingly patient-centric way in which life science companies are doing business today: How to treat the data collected by the apps provided with drugs and devices.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Chen Yang
Sydney, Hong Kong
cyang@sidley.com
Olivier Goarnisson
Torrey Cope
Washington, D.C.
tcope@sidley.com