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Regulation

Set Alert for Regulation

Action Needed To Prevent Post-Brexit Catastrophe In Northern Ireland

Action is needed from both the UK government and the European Commission to prevent a collapse of Northern Ireland’s generics market, according to the BGMA.

Regulation United Kingdom

FTC Wins Backing Over Pay-For-Delay Decision

The FTC has won the backing of an appeals court over its 2019 decision that found a reverse-payment settlement deal between Impax and Endo over Opana ER to be anti-competitive and illegal.

Legal Issues Regulation

Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

Generic Drugs Strategy

FDA Guides On Virtual Inspections During COVID-19

Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.

Guidance Documents Regulation

Biosimilars Bodies Urge Communication Enhancements For BsUFA III

Biosimilars industry stakeholders have suggested ways to enhance communication and improve the US regulatory pathway for biosimilars, as they weighed in on an interim assessment of the program for enhanced review transparency and communication in the Biosimilar User Fee Act II, ahead of the upcoming reauthorization of BsUFA for fiscal years 2023 through 2027 by the FDA. 

Biosimilars Regulation

Tentative Biosimilar Approvals Under Consideration By FDA

Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.

Biosimilars Regulation
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