OR WAIT null SECS
April 02, 2013
The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.
March 02, 2013
Vaccine development is benefiting from manufacturing advances and support for global health.
February 02, 2013
Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.
December 02, 2012
White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.
November 02, 2012
Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
October 02, 2012
The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.
September 02, 2012
Import controls and risk strategies aim to promote quality and spur new drug development.
August 02, 2012
July 02, 2012
A Q&A with FDA Deputy Commissioner Deborah Autor.
June 02, 2012
New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.