The US Food and Drugs Administration’s (FDA) Centre for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are going to work together to streamline their efforts for inspections and facility evaluations for human medicines. The plan is to become operational in autumn of 2017.
This follows the User Fee agreement being reauthorized which states that agency will provide final inspection classifications within 90 days for generic drug makers from October 2018.
The plan contains operating models for pre-approval, post-approval, surveillance and for-cause facility inspections. The hope is that there will be consistency, transparency and efficiency during the evaluations and inspections as well as improvements in the operational capacity of the FDA.
To read the white paper on the FDAs concept of operations, click here.