Regulatory Oversight and Compliance

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.

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.

EMA Accepts Three Organizations into ATMP Pilot Program

February 09, 2024

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

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.

Compounding Overview: Primary Considerations for the Workplace

February 03, 2024

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

EMA Given Grant to Support Establishment of African Medicines Agency

February 02, 2024

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

MHRA’s New International Recognition Procedure

February 02, 2024

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

FDA Issues Guidance on CAR-T Cell Product Development

February 01, 2024

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.