FDA publishes guidance on providing regulatory submissions in electronic format addressing pharmaceutical production applications and related submissions in the Federal Register Oct. 19. Guidance outlines filing of NDAs, ANDAs, BLAs, INDs, master files and promotional materials using the electronic Common Technical Document. One in a series of documents, the guidance is intended to facilitate use of the eCTD specifications and provides more specificity than previous guidance documents. The agency is accepting comments...
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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.’
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
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.
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.
