FDA faces allegations over ‘capricious’ allergy drug approval

Endo and its subsidiary have challenged the FDA's approval of an application by BPI Labs and Belcher Pharmaceuticals | Dispute argues the FDA undermined regulatory frameworks and patent protection.

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Paul Hastings hires ex-FDA policy director

5 March 2024 Firm hires former Food and Drug Administration staffer from King & Spalding | Washington DC office gains nearly a decade of FDA experience.

Medtech

Judge tears into ‘safe harbour’ ruling in heart valve system case

26 March 2024 Judge’s dissenting opinion challenges the interpretation of the safe harbour provision by the US Court of Appeals for the Federal Circuit | Decision concerns Meril's importation of transcatheter heart valve systems in a dispute with Edwards Lifesciences | Court majority upheld the district court's ruling favouring Meril.

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Careers

Paul Hastings hires ex-FDA policy director

5 March 2024 Firm hires former Food and Drug Administration staffer from King & Spalding | Washington DC office gains nearly a decade of FDA experience.

Medtech

Judge tears into ‘safe harbour’ ruling in heart valve system case

More on this story

Careers

Paul Hastings hires ex-FDA policy director

5 March 2024 Firm hires former Food and Drug Administration staffer from King & Spalding | Washington DC office gains nearly a decade of FDA experience.

Medtech

Judge tears into ‘safe harbour’ ruling in heart valve system case