08.09.25 -- Pharmaceutical Online Best Of July

The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

In this Pharmaceutical Online Live event, our panelists discuss the importance and need for clarity and guidance around peptide clean room requirements.

The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

The revised EU GMP Annex 1 mandates a comprehensive Contamination Control Strategy, continuous environmental monitoring, and species-level contaminant identification to ensure compliance.

Is your cleaning validation process truly aligned with current expectations? This checklist helps you implement a risk-based approach, focusing resources to effectively mitigate your highest-risk areas.