ONP: Leaner, Meaner In 2006
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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Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.