EMA and FDA publish joint QbD guidance on design space verification.
FDA and the European Medicines Agency (EMA) have published a second joint question-and-answer document that provides guidance on the quality-by-design (QbD) concept. The guidance focuses on design space verification and reflects the conclusions reached by European Union and US regulators.
In March 2011, FDA and EMA launched a three-year pilot program for the parallel assessment of certain quality or chemistry manufacturing and control (CMC) sections of applications that are relevant to QbD. The objective of the program is to share knowledge and harmonize implementation of the QbD concept. Experts from the Japanese Pharmaceuticals and Medical Devices Agency participate as observers in the program.
According to EMA, the pilot program is open to selected procedures, including applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot program is voluntary. Interested applicants and sponsors should notify both agencies three months prior to submission of an application.
Source: European Medicines Agency
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.