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.

Manufacturing 72

Manufacturing Healthcare Contract Government 72

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.

Contract 76

Contract Manufacturing Statute Contract Law 76

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.

Litigation 52

Litigation Litigating Manufacturing Contract 52

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.

Court 72

Court Government Compensatory Damages Litigation 72

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. ,

Litigation 40

Litigation Litigating Court Laws 40

ClimateChange-ClimateLaw

MARCH 6, 2018

DECISIONS AND SETTLEMENTS. The Ninth Circuit Court of Appeals reversed a district court decision that vacated the listing of the Arctic ringed seal as threatened under the Endangered Species Act (ESA). Jacobson’s lawsuit asserted defamation, breach of contract, and promissory estoppel claims.

Court 40

Court Government Laws Litigation 40