The American Academy of Pediatrics states it is "premature to recommend the administration of activated charcoal" as an alternative to ipecac syrup to treat ingestion of a potentially poisonous substance in a Nov. 3 1policy statement. Charcoal is "poorly accepted by young children" and does not store well in the home, the statement says. However, AAP adds that ipecac should "no longer be used routinely as a home treatment strategy" either. The use of activated charcoal in conjunction with ipecac syrup was discussed at Nonprescription Drugs Advisory Committee's June 2003 meeting on retaining ipecac's current OTC status (2"The Tan Sheet" June 2, 2003, p. 5)...
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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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Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.