Topic

Claude Price is the head of Clinical Data Management at Quanticate.

Articles

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.

The Importance of Quality Data for Regulatory Submissions

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

FDA Gives Guidance on Developing Treatments for Early Alzheimer’s

Feliza Mirasol is the science editor for 

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

Videos

This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

Drug Digest: The Rush for Quality Data and the Means to Protect It

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.

Quality Systems