OCTAPHARMA USA, INC. et al v. BECERRA et al
Case Number:
1:22-cv-02782
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February 08, 2024
FDA Settles Allegations Of Uneven Blood Treatment Standards
The U.S. Food and Drug Administration has settled a pharmaceutical company's lawsuit in D.C. federal court accusing the agency of subjecting the company's blood-clotting medication to costly clinical trials and higher standards than its competitors' products were required to meet.
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September 14, 2022
Pharma Co. Challenges FDA's 'Uneven' Blood Drug Standards
The maker of blood treatment Fibryga hit the U.S. Food and Drug Administration with a suit on Wednesday in D.C. federal court over what it says are the agency's "sharply uneven" standards for blood medications, arguing it was subjected to multimillion-dollar clinical trials while competitors were allowed to skip the "critical step."