FDA Publishes Guidance on Drug Effectiveness
The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
On March 14, 2019, FDA published guidance intended to help with the development of enrichment strategies used in clinical investigations to demonstrate the effectiveness of drug and biological products. The guidance focuses on improving the ability of a study to detect a drug’s effectiveness, but similar strategies can be used in safety strategies.
The guidance defines enrichment as “the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population.” The document discusses precision medicine and the interpretation of studies. Specifically, the guidance addresses decreasing variability, identifying high-risk patients and more responsive patients, and regulatory issues.
Source: FDA
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma
March 8th 2025In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
