FDA Finalises Drug-Labeling Framework for Sponsor Software
Final FDA guidance treats certain outputs from drug-linked software as prescription-drug labeling and explains sponsor submission duties.
United StatesFinal FDA guidance treats certain outputs from drug-linked software as prescription-drug labeling and explains sponsor submission duties.
United StatesA Guatemalan national extradited to the United States received a 30-year sentence over a 2022 trailer journey that killed 53 people.
Gellert Global has asked the US Court of International Trade to invalidate 50 per cent duties imposed on Canadian goods under section…
The SEC and France’s AMF have established a consultation and information-sharing framework for cross-border investment supervision.
The Employment Appeal Tribunal upheld the unfair-dismissal finding but required reconsideration of procedural defects and the Polkey reduction.
The UK Supreme Court restored HMRC’s victory over deductions claimed for customer-redress payments made under Ofgem settlements.
The High Court set aside regulations that barred new puberty-blocker prescriptions for gender dysphoria, finding consultation and rights defects.
A federal court in Mississippi has dealt a setback to the Trump administration’s effort to end a civil rights lawsuit accusing Elon…
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