International- Regulators discuss accelerated approvals, Project Orbis at DIA

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to...

International – How regulators have adapted globally to clinical trials for drugs and biologics...

The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020....
WHO drafts guidance for pharma supply chain tracking

International – WHO drafts recommendations for regulatory reliance

The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making...
WHO drafts guidance for pharma supply chain tracking

International – Rituximab biosimilar prequalified by WHO

The World Health Organization (WHO) has prequalified South Korean drugmaker Celltrion’s biosimilar version of rituximab, the second product achieving that status under a biosimilar...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH updates on upcoming guidelines, adds new participants

The International Council for Harmonisation (ICH) on Wednesday announced the addition of a new member and observer to its ranks and updated on the progress of...

International – FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan...

Given the global public health crisis resulting from the coronavirus disease 2019 (COVID-19) pandemic, FDA and EMA are providing procedural assistance to sponsors and...
WHO Drafts Guideline on Data Integrity for Pharmaceuticals

International – WHO reviewing hydroxychloroquine safety data

The World Health Organization (WHO) on Tuesday promised a swift review of data on hydroxychloroquine, probably by mid-June, after safety concerns prompted the group...

International – Un infectiologue marocain conteste l’étude de The Lancet sur la chloroquine

L’épidémiologiste et infectiologue marocain, le Pr Jaâfar Heikel, directeur général d’une clinique privée qui soigne dans le cadre d’un volontariat les malades atteints du...

International – Medical Writing: The Language and Art of Scientific Communication

Medical writers (MWs) are professionals from diverse backgrounds who address different business needs. Writers hone their skills over the years and master the art...

International – INSTITUT PASTEUR : Comment l’étude des mécanismes de multiplication du SARS-COV-2 permet...

Une initiative internationale regroupant des chercheurs de l’Université Californienne de San Francisco (UCSF), des Gladstone Institutes, de l’Icahn School of Medicine at Mount Sinai et de...

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