Quality

BioPharm International: Feb 24, 2015
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.
BioPharm International: Feb 24, 2015
By BioPharm International Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.
BioPharm International: Feb 23, 2015
By BioPharm International Editors
The agency cites Apotex’s Bangalore facility with quality system failures.
BioPharm International: Feb 17, 2015
By BioPharm International Editors
FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.
BioPharm International: Feb 17, 2015
By BioPharm International Editors
The agency releases five draft guidance documents related to drug compounding and repackaging.
BioPharm International: Feb 04, 2015
By BioPharm International Editors
FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.
BioPharm International: Feb 01, 2015
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
BioPharm International: Feb 01, 2015
As ADCs move through the drug-development process, different analytical methods are often required.
BioPharm International: Jan 23, 2015
By BioPharm International Editors
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
BioPharm International: Dec 01, 2014
Performing degradation studies is the best strategy to evaluate toxicity risk.