Day: March 26, 2026

For decades, the Limulus Amebocyte Lysate (LAL) test has served as the gold standard for detecting bacterial endotoxins, yet evolving manufacturing complexities demand a more nuanced regulatory approach. The FDA’s updated guidance on pyrogen and endotoxin testing marks a significant shift, bridging the gap between legacy methodologies and modern analytical capabilities. As product portfolios expand … Read more

Although 3D printing for drugs and biologics still has ways to go to become common, the FDA and EMA have been receptive to proposal for products using this technology. As 3D printing (3DP) moves from rapid prototyping to the mass customization of solid oral dosage forms, regulatory frameworks are rapidly evolving to catch up with … Read more