MAGNESIUM CITRATE LAXATIVE OTHER THAN IN ORAL SOLUTION is not allowed under the tentative final monograph for OTC laxatives, FDA told Purdue Frederick in a December letter. The Norwalk, Conn.-based firm had asked FDA in October 1994 to give monograph status to a formulation of magnesium citrate 25 g in a solid mixture that must be reconstituted before oral administration. The agency decided that the information provided by Purdue Frederick did not "support the requested revision."
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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.
