Quality Systems

WHO Warns About Falsified Ozempic Batches

June 24, 2024

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

EMA Reviews Risks of CAR T-Cell Medicines and Painkillers

June 19, 2024

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

Understanding Excipient Characteristics to Ensure Robust Continuous Manufacturing

June 13, 2024

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Determination of Shelf-Life from Stability Data: From Replicates or from Averages?

June 11, 2024

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

CDER Announces Emerging Drug Safety Technology Meeting Program

June 10, 2024

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

Drug Shortage Reports Emphasize Continuing Problems

June 10, 2024

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

Diversifying the Supply of Raw Materials

June 08, 2024

The final drug product relies on the quality and reliability of the raw materials used in its production.

The Need for Automated and Standardized CGT Manufacturing (BIO 2024)

June 07, 2024

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

Using RWD in Non-Interventional Studies

June 05, 2024

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

CGT Catapult and CATTI Establish Shared Training Standards for Advanced Therapies

June 04, 2024

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.