Quality Systems

Europa Perspectives: Helping to Navigate the Regulatory System

February 23, 2024

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

FDA’s Drug Safety Priorities for 2023

February 21, 2024

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

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

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

European Medicines Agency Viewpoint

February 17, 2024

Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.

EMA and HMA Launch Real-Word Data Catalogues

February 16, 2024

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

Ensuring Quality in Contracted Support

February 15, 2024

This article looks at the relationship between a CDMO quality organization and the client.

How to Evaluate a CDMO’s Commitment to Quality

February 15, 2024

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?

EMA Issues Reminder Over Paxlovid Risks

February 12, 2024

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

February 07, 2024

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

AbbVie Gains Nod from NICE for Tepkinly

February 04, 2024

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.