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Nov 13, 2024 | 
natlawreview.com | Chia-Feng Lu
China’s innovative drug market is projected to grow from RMB 709.7 (USD 99) billion in 2023 to RMB 753.4 (USD 105) billion in 2024, drawing mixed reactions from international pharmaceutical companies. On one hand, a number of multinational companies exercised lingering caution over additional investments in China. For example, in August, UCB divested part of its mature neurology and allergy products as well as a manufacturing site to private equity, CBC and Mubadala.
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Jul 24, 2024 | 
natlawreview.com | Chia-Feng Lu
China’s life sciences sector is undergoing significant transformation due to recent technological advancements, legislative changes, and regulatory reforms aimed at balancing risk mitigation with innovation.
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Apr 3, 2024 | 
natlawreview.com | Chia-Feng Lu
Skip to main content April 03, 2024 Volume XIV, Number 94 Legal Analysis. Expertly Written. Quickly Found.
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Mar 7, 2024 | 
natlawreview.com | Thomas Kane |Lauren Cooper |Eric Troutman |Chia-Feng Lu
On March 4, 2024, the California Supreme Court ruled in Niedermeier v. FCA that consumers forced to trade in or sell their defective vehicles due to a manufacturer’s failure to comply with the Song-Beverly Consumer Warranty Act, California Civil Code section 1793 et seq., (the “Act”) should not have their restitution reduced by the money they received from the trade-in or sale. This case is significant as it resolved a split in California’s appellate courts.
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Mar 7, 2024 | 
natlawreview.com | Chia-Feng Lu
In December 2023, China’s National Healthcare Security Administration (NHSA) published the 2023 National Reimbursement Drug List (2023 NRDL), implementing a comparable level of pricing discounts to those seen in 2021. This GT Advisory explores the following:A total of 126 drugs were added to the 2023 NRDL, and one drug was removed. Out of 143 negotiated drugs/drugs participating in bidding, 121 drugs were successfully included in the final NRDL, a historic high.
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Mar 6, 2024 | 
mondaq.com | Chia-Feng Lu |Caroline Abbott
Go-To Guide:
The U.S. Food and Drug Administration (FDA) accepted its first
artificial intelligence (AI)-based and digital health
technology-based project and the first in neuroscience into its
ISTAND Pilot Program.
The technology gathers a multitude of patient data to build a
quantitatively informed profile of a patient's mental health,
used to assist in monitoring and measuring treatment response,
progress, and efficacy in clinical trials.
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Feb 26, 2024 | 
lexology.com | Chia-Feng Lu |Caroline Abbott
Go-To Guide:The U.S. Food and Drug Administration (FDA) accepted its first artificial intelligence (AI)-based and digital health technology-based project and the first in neuroscience into its ISTAND Pilot Program. The technology gathers a multitude of patient data to build a quantitatively informed profile of a patient’s mental health, used to assist in monitoring and measuring treatment response, progress, and efficacy in clinical trials.
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Jan 26, 2024 | 
natlawreview.com | Chia-Feng Lu
Skip to main content January 26, 2024 Volume XIV, Number 26 Legal Analysis. Expertly Written. Quickly Found.
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Jan 16, 2024 | 
natlawreview.com | Chia-Feng Lu
The U.S. Food and Drug Administration (FDA) has demonstrated increased interest in “off-label” communications in recent years. Together with uncertainty following recent FDA guidance changes and the agency’s increasingly broad discretion, this growing interest means greater regulatory risk for firms. Go-To Guide:FDA continues growing its interests in “off-label” communications.
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Jan 16, 2024 | 
lexology.com | Chia-Feng Lu
The U.S. Food and Drug Administration (FDA) has demonstrated increased interest in “off-label” communications in recent years. Together with uncertainty following recent FDA guidance changes and the agency’s increasingly broad discretion, this growing interest means greater regulatory risk for firms. Go-To Guide:FDA continues growing its interests in “off-label” communications.
