Director of the Office of Nonprescription Products Charles Ganley, MD, and Assistant Director Susan Johnson, PhD, met with industry stakeholders at a conference Feb. 1 to present an overview of the status of ONP in 2006. The department heads discussed FDA's plans to set a final deadline on monograph clearance and improve internal communication and NDA review, and made several suggestions on how industry can help FDA do its job..
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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.’
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
