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Latest From Ian Schofield
A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.
A listing of EU centralized approvals of new active substances, including brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Medicine shortages are under scrutiny at national and EU level. In France, a newly established Senate task force is hearing evidence from a range of stakeholders including industry and regulators.
New rules on the regulation of autologous human cell and tissue products have been introduced in Australia, together with clearer definitions of biological products.
A pilot project run by the European Pharmacopoeia is being expanded in an effort to produce general quality standards for monoclonal antibodies, following the adoption of a monograph for infliximab last November.