USA – Clinical trials: FDA proposes new standards for collecting race, ethnicity data
The US Food and Drug Administration (FDA) is outlining a standardized approach for collecting and reporting on race and ethnicity data in clinical trials...
UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
The CD19-directed antibody-drug conjugate (ADC) has specifically been recommended for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade...
USA – FDA issues QMSR final rule with 2-year transition period
The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a...
Europe – Clinical trials’ transition to new EU system – one year left
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks...
USA – FDA: Genome editing therapies may use accelerated approval pathway
The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors developing gene therapy products that incorporate genome editing (GE) of human...
Europe – Experts outline challenges of combination products in Europe
Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director...
USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary...
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide...
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born...
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
The committee recommended granting a marketing...
