Contract Court Decisions Manufacturing Statute 
FDA Law Blog
MAY 30, 2024
Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.
FDA Law Blog
NOVEMBER 30, 2022
Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C In addition, Grifols’s eligibility for government contracts is conditioned on FDA approval of Gamunex and FDA approval is conditioned on compliance with GMPs.
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Patently O
FEBRUARY 10, 2022
The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. The Federal Circuit relies upon traditional contract law principles to determine whether a particular communication constitutes such an offer. Remember the contract foundational trio: Offer, Acceptance, Consideration.
At the Lectern
MAY 30, 2024
.’ ” The appellate court also found inapplicable the Legislature’s intent statement in newly enacted Assembly Bill 600 that, in resentencing proceedings under section 1172.1 , which the bill amended, “courts have full discretion. ” The urging went unheeded, except for Justice Evans. ” (See also here.)
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.
ClimateChange-ClimateLaw
OCTOBER 20, 2020
1442, or the civil-rights removal statute, 28 U.S.C. The district court rejected eight grounds for removal, but the Fourth Circuit concluded its appellate jurisdiction was limited to determining whether the companies properly removed the case under the federal-officer removal statute. Mayor & City Council of Baltimore , No.
ClimateChange-ClimateLaw
SEPTEMBER 10, 2021
The New Jersey court also found no basis for Grable jurisdiction, rejecting the companies’ arguments that the City’s claims necessarily raised substantial and actually disputed issues of federal law such as First Amendment issues or issues addressed by federal environmental statutes. Northern Plains Resource Council v. BP p.l.c. ,
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