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Adaptive licensing and facilitated regulatory pathways: A survey of stakeholder perceptions

(2015) L Liberti et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regulatory framework for access to safe, effective quality medicines

(2014) Lembit Rägo et al.   ANTIVIRAL THERAPY

Accelerated Access to Innovative Medicines for Patients in Need

(2014) L G Baird et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A Universal Framework for the Benefit-Risk Assessment of Medicines

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Use of Multiple Endpoints and Approval Paths Depicts a Decade of FDA Oncology Drug Approvals

(2013) M. B. Shea et al.   CLINICAL CANCER RESEARCH

Regulatory Review: How Do Agencies Ensure the Quality of Decision Making?

(2013) L Liberti et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Food and Drug Administration Amendments Act and Postmarketing Commitments

(2013) Kevin Fain et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

A Review of Regulatory Mechanisms Used by the WHO, EU, and US to Facilitate Access to Quality Medicinal Products in Developing Countries With Constrained Regulatory Capacities

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