Calendaring Litigating Manufacturing 
SCOTUSBlog
SEPTEMBER 29, 2023
The question comes to the court in the case of George Sheetz , who in 2016 applied for a permit to build a 1,854-square-foot manufactured home on land that he owns in Placerville, California. The post Twelve cases added to Supreme Court calendar appeared first on SCOTUSblog. The plaintiff in the case, Yonas Fikre, is a U.S.
FDA Law Blog
JANUARY 5, 2023
To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
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FDA Law Blog
SEPTEMBER 30, 2024
CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.
FDA Law Blog
JANUARY 1, 2024
It’s why litigators concentrate on their opening statement to a jury, and their closing argument. Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Farquhar & Aisha T. They have great impact on most companies that receive them.
FDA Law Blog
AUGUST 29, 2024
After all, as we have written before in other contexts ( i.e. , the BLOCKING Act), “[I]f you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. And like its predecessor bills, S. 142 includes narrow exceptions: (B) Exception.
Patently O
SEPTEMBER 20, 2021
Eligibility : The Supreme Court has shown the most interest in hearing American Axle & Manufacturing, Inc. I expect for the SG to file a brief by the end of calendar year 2021. Kessler allows for non-mutual issue preclusion even in cases where the particular issue was not actually litigated or decided. Patreon, Inc.
SCOTUSBlog
NOVEMBER 17, 2023
Raimondo headline the calendar for the January argument session , which the court released on Friday morning. 9) – Property-rights challenge by California landowner to nearly $24,000 in development fees levied by the county as a condition for receiving a permit to build a manufactured home. Relentless, Inc. County of El Dorado (Jan.
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