Quality Systems

Feliza Mirasol is the science editor for 

Articles

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

EMA Validates Parallel Applications for Datopotamab Deruxtecan in Two Types of Cancer

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

Europe's DARWIN EU Data Program Adds Capacity

FDA has published final guidance documents regarding validation and development of analytical procedures.

Final Analytical Procedures Guidance Published

Amin Ziaie, QRM Merck & Co., Inc, PRST, the Technological University Dublin.

Anne Greene, PhD, is director PRST, Technological University Dublin.

Martin J. Lipa, PhD, martin.lipa@prst.ie, is a senior research fellow at Pharmaceutical Regulatory Science Team.

This article explores the emergence of subjectivity in ICH Q9 (R1).

Shining a Light on the Long Shadow of Subjectivity in Quality Risk Management

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

Updating Swiss Regulatory Processes in 2024

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

EMA Recommends New ALS Treatment

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Europa Perspectives: Helping to Navigate the Regulatory System

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

FDA’s Drug Safety Priorities for 2023

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Regulatory Oversight and Compliance