Articles tagged with “biologics”

Biologics Comparability: A Guide to ICH Q5E & CMC Changes

An educational guide to biologics comparability studies. Learn how to prove "no meaningful change" after manufacturing process changes, based on ICH Q5E and FDA

50 min read

1/6/2026

comparability study biologics ich q5e cmc manufacturing changes regulatory affairs analytical characterization post-approval changes

PLLR for Biologics: Drafting Clear Pregnancy Risk Summaries

Learn how the FDA's PLLR replaced old pregnancy categories. This guide explains how to draft clear pregnancy risk summaries for complex biologics with limited d

50 min read

11/23/2025

pllr pregnancy risk summary biologics fda labeling drug safety regulatory affairs monoclonal antibodies medical writing

Global Pharmaceutical Market: 2025 Analysis & Key Trends

A detailed analysis of the global pharmaceutical market, forecast to reach $1.6T by 2025. Explore key growth drivers, therapy areas, and industry challenges.

135 min read

10/14/2025

pharmaceutical industry pharma market analysis specialty medicine biologics oncology market drug pricing patent cliff pharmerging markets