by Michele Taylor | Oct 17, 2016
Theresa Mullin, Ph.D. and Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research recently posted a blog on FDA Voice updating about the progress that has been made in the effort to listen and capture patient perspectives on the...
by Michele Taylor | Oct 7, 2016
Pharma groups use quality metrics to monitor their own quality and identify areas to improve. FDA will soon be requesting this valuable data and making use of it – a revision to the FDA’s draft guidance on quality metrics is planned still for 2016. FDA plans to use...
by Michele Taylor | Sep 27, 2016
Final ruling from the FDA was released on 9/6 that gives manufacturers of consumer antibacterial wash one year to remove 19 banned ingredients from their products. The ingredients are not generally recognized as safe and effective and consumer antibacterial washes...
by Michele Taylor | Sep 26, 2016
There is still time to register today for the October 3rd ACRP Circle City Chapter 16th annual fall symposium at the Ritz Charles in Carmel, IN. Pearl Pathways’ CEO and President Diana Caldwell will moderate a panel discussion of The Future of Research in Indiana. ...
by Michele Taylor | Sep 14, 2016
Our partner, Brandwood Biomedical, is hosting a complimentary webinar Tearing down the Tower of Babel — Asia Pacific Product Labeling. Join in the discussion on how regulatory affairs professionals deal with the many challenges of labeling requirements across...