Meena Datta examines proposed new legislation that would authorise the Health and Human Services Secretary to negotiate prices directly with prescription drug manufacturers.
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.
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 Sommer2021-10-28 14:50:012022-04-27 14:20:10Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions
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.
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Coleen Klasmeierhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngColeen Klasmeier2021-10-06 14:56:532022-04-27 13:53:56What Do the FDA’s Expanded ‘Intended Use’ Regulations Mean for Safe-harbored Communications about New Uses?
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-03.png606833Chen Yanghttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChen Yang2021-09-17 14:43:002022-05-09 14:48:10Pharmacovigilance Considerations in the Era of Patient Centricity: Data Collected by Apps
This month’s presidential Executive Order on economic competitiveness in the U.S. includes a number of initiatives relating to drug pricing. There are calls to combat “excessive pricing,” to reduce the cost of drugs to the Federal government, to address “price gouging” and to promote low-cost generics and biosimilars.
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 Datta2021-07-13 14:41:342022-07-14 14:27:39Moves to Lower Drug Prices in Biden’s Executive Order on Competitiveness
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.
(more…)
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.
(more…)
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.
(more…)
Jonathan Tomlin
London
jtomlin@sidley.com
Elizabeth C. Curtin
Chicago
ecurtin@sidley.com
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.
(more…)
Coleen Klasmeier
cklasmeier@sidley.com
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.
(more…)
Chen Yang
Sydney, Hong Kong
cyang@sidley.com
Olivier Goarnisson
Geneva
ogoarnisson@sidley.com
Torrey Cope
Washington, D.C.
tcope@sidley.com
Moves to Lower Drug Prices in Biden’s Executive Order on Competitiveness
This month’s presidential Executive Order on economic competitiveness in the U.S. includes a number of initiatives relating to drug pricing. There are calls to combat “excessive pricing,” to reduce the cost of drugs to the Federal government, to address “price gouging” and to promote low-cost generics and biosimilars.
(more…)
Meenakshi Datta
Chicago
mdatta@sidley.com
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