FDA is working on three guidances to help avoid medication errors due to drug name confusion. The first addresses policy considerations related to the process of submitting trade names, such as what FDA will and will not accept; another guidance provides general recommendations on labeling and packaging issues, including prominence and total drug content; the third will provide more specifics on the analysis and submission of data for trade name review, including possible studies companies could conduct to evaluate look-alike and sound-alike names
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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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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.