Daria G. Husni

Daria G. Husni is Assistant Editor for BioPharm International.

Articles

FDA Releases Guidance on Standards Related to Pharmaceutical Quality

The program aims to aid submissions from external stakeholders and FDA staff.

FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals

The guidance document outlines recommendations to limit potential carcinogenic risk.

Update on Storm Damage to Pfizer Facility in North Carolina

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

EMA Extends OPEN Framework to More Medicines

The framework is now expanded beyond COVID-19 vaccines and treatments.

EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

EU Takes Steps to Prevent Antibiotic Shortages Next Winter

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.