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The Benefit-Risk Assessment of Medicines: Experience of a Consortium of Medium-Sized Regulatory Authorities

• Authors : McAuslane, Neil; Leong, James; Liberti, Lawrence

• Source: Therapeutic Innovation and Regulatory Science; September 2017, Vol. 51 Issue: 5 p635-644, 10p

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An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency

• Authors : Dörr, Petra; Wadworth, Alison; Wang, Tina

• Source: Therapeutic Innovation and Regulatory Science; November 2016, Vol. 50 Issue: 6 p734-742, 9p

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A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?

• Authors : Walker, Stuart; McAuslane, Neil; Liberti, Lawrence

• Source: Therapeutic Innovation and Regulatory Science; January 2015, Vol. 49 Issue: 1 p17-25, 9p

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Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies

• Authors : Liu, Li-Ling; McAuslane, Neil; Tzou, Meir-Chyun

• Source: Therapeutic Innovation and Regulatory Science; November 2013, Vol. 47 Issue: 6 p678-683, 6p

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Accelerated approval of medicines: fit for purpose?

• Authors : Breckenridge, Alasdair; Liberti, Lawrence

• Source: Nature Reviews Drug Discovery; June 2018, Vol. 17 Issue: 6 p379-380, 2p

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Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.

• Authors : van der Zee, Ivar T.¹; Vreman, Rick A.¹; Liberti, Lawrence²

Subjects: *DRUG approval; *COVID-19; *SCIENTIFIC observationLATIN America

• Source: Revista Panamericana de Salud Pública. 2022, Vol. 46, p1-7. 7p.

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