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New European Union (EU) pharmacovigilance legislation, effective from July 2012, introduced new concepts and procedures to optimise the way medicines are regulated within the Union and provided new channels for public health interventions. Triggered by the EU legislation, the work done by the International Conference on Harmonisation (ICH) has provided a common standard for periodic benefit-risk evaluation reporting within the ICH regions. The present paper provides a review of the concepts behind the use of periodic benefit-risk evaluation reports (PBRER) in supporting safety evaluation and assessment of benefit-risk balance and covers essential points in the documentation of safety information, risk evaluation and benefit-risk assessment. The review incorporates the experience to-date with the PBRER at EU level led by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. The scope of the PBRER, the main content topics and the challenges relevant to the different stakeholders are highlighted together with key success factors for the report to deliver its objectives and maximise the use of the regulatory assessment procedure. It is clear that the PBRER extends beyond new ways of data presentation and analysis and reflects a further shift in pharmacovigilance in the EU towards more integrated benefit-risk assessment of marketed medicines. [ABSTRACT FROM AUTHOR]

The GAIN Act, combined with previous US FDA regulations and in the setting of new guidance and related advisory committee recommendations, provides a path forward to expedite development of new anti-infective products that fulfill unmet need related to treatment of antibiotic-resistant organisms. Unresolved issues include the role of superiority versus non-inferiority trials in the approval of new drugs and the nature of the data package that could support the approval of a drug active against resistant organisms. This paper discusses both these issues and suggests paths forward, while acknowledging the concerns that expedited development will lead to greater uncertainty in efficacy and safety. [ABSTRACT FROM AUTHOR]