Any parallel product review process developed by FDA and CMS should not involve new requirements for comparative effectiveness data, the Medical Innovation and Competitiveness Coalition urges in recent comments to the agencies.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
