Listen to the patient and learn

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...

FDA wants your data…

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  FDA will soon be requesting this valuable data and making use of it – a revision to the FDA’s draft guidance on quality metrics is planned still for 2016.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...

Looming deadline for manufacturers of antibacterial wash

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...