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Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

Europe Publishes Electronic Product Information for Selected Medicines

The document includes recommendations for the reporting and implementation of changes to container closure system components.

FDA Publishes Guidance on Container Closure Systems for COVID-19 

Feliza Mirasol is the science editor for 

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study  is following ISO or USP standards. 

Discussing E&L Study Design Between ISO and USP (AAPS PharmSci 360) 

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

This is the second biologic approved to treat HS, a painful and reoccurring skin disease. 

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

The EC is calling for interested parties for their safety and orphan drug committees.

European Commission Searches for Committee Experts

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

Prasanth Sambaraju is an independent researcher based in Hyderabad, India. 

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability. 

Pooling of Batches for Stability Data Analysis

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

Quality Systems