The Office of Pharmaceutical Quality (OPQ) was launched in early 2015 with a slogan of “One Quality Voice”. With Michael Kopcha, Ph.D., R.Ph. as the Director of the Office of Pharmaceutical Quality at CDER, and with approximately 1000 personnel in his group, OPQ’s objectives are as follows: a) streamline the regulatory processes and integrate major functional areas to facilitate a lifecycle approach to quality starting from pre-approval to post-product approval for branded and generic drug products;
Will there be more CRLs to come inspectional and manufacturing deficiencies based on the new integrated review process within the Office of Pharmaceutical Quality? Will FDA truly speak with one quality voice by integrating review and inspection across product review disciplines?
The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.