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Don’t miss updates on recent news in accelerated trials and its implications for drug development in the United States.
Pink Sheet’s analysts take you behind the headlines for an in-depth analysis of the use of the US Accelerated Approval Program and what it may mean for the future of the US pharma industry.
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Pink Sheet: global policy and regulatory coverage
By Ian Schofield 19 Jan 2022
Proposals for averting medicines supply disruptions caused by Brexit in Northern Ireland and three EU markets are about to be...
Pink Sheet: global policy and regulatory coverage
By Francesca Bruce 19 Jan 2022
As well as recommending Seagen’s Tukysa and Daiichi Sankyo/AstraZeneca’s Enhertu, the Scottish Medicines Consortium has given the green light to...
Pink Sheet: global policy and regulatory coverage
By Bridget Silverman 19 Jan 2022
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
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