FDA drug approval application form: FDA announces availability of revised form FDA 356h for use by applicants submitting all NDAs and ANDA/AADAs in the July 9 Federal Register. The revised form replaces the FDA 356h for NDAs, ANDAs/AADAs revised in October 1993. FDA says it "believes that a harmonized application format will allow companies to provide higher quality submissions, reduce preparation time, expedite review by FDA and easily adapt to electronic submissions when that becomes possible and practical." Applicants can use the form now; its use will be required beginning Jan. 8...
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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.’
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
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