Court Decisions Litigation Manufacturing 
FDA Law Blog
APRIL 6, 2025
This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.
SCOTUSBlog
JANUARY 24, 2025
The question comes to the court as part of the FDAs efforts to regulate the multibillion-dollar vaping industry. What arguments could you raise, she queried, that would be different than the manufacturer? As a practical matter, he asked Suri, why is it inconvenient for the government to litigate in one circuit instead of another?
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FDA Law Blog
SEPTEMBER 29, 2021
The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.
Law 360
AUGUST 13, 2024
Chip manufacturer Nvidia Corp. Supreme Court victory over investors who accuse the company of downplaying its reliance on the crypto mining market, arguing that a lower court decision allowing the case to move forward "eviscerates the guardrails that Congress erected to protect the public from abusive securities litigation."
ClimateChange-ClimateLaw
MARCH 27, 2025
The Court viewed this structure as evidence that Congress intended to preempt state regulations that bear on the performance of a [covered] product as manufactured. District Court for the Northern District of California, which ruled that EPCA did not preempt Berkleys ordinance. A trade group first challenged the law in the U.S.
FDA Law Blog
DECEMBER 7, 2023
Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. FTC Supreme Court decision stripping FTC of its ability to obtain restitution or disgorgement under Section 13(b) of the Federal Trade Commission Act. By Steven J.
Patently O
FEBRUARY 24, 2022
Eligibility under Section 101 : American Axle & Manufacturing, Inc. 20-1394 (CVSG requested October 4, 2021); Undermining Jury Decisions : Olaf Sööt Design, LLC v. Rather, an appellant must show concrete injury caused by the PTAB decision and redressability of that injury. Neapco Holdings LLC, et al. , Patreon, Inc.,
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