Quality Systems

Being Innovative in CGMP Training While Adapting to Change

September 19, 2023

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment

September 19, 2023

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

September 18, 2023

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

FDA Issues Guidance on Biosimilar Labeling

September 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Colorcon Launches New Titanium Dioxide Free Moisture Protection Coating for Pharmaceutical Tablets

September 14, 2023

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

FDA Establishes Stabilization Period for Updated DSCSA Compliance Policies

September 08, 2023

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Dealing with Data: How to Keep It Manageable

September 06, 2023

Advanced analytical tools generate more data in today’s labs than ever before.

In Equal Measures: The Importance of Excipient Quality

September 03, 2023

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

The Future is the Present: Artificial Intelligence in Pharmaceutical Manufacturing

September 03, 2023

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Knowledge as the Currency of Managing Risk: A Smart Investment for Patients

September 03, 2023

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.