FDA May Require Drug Importers To Verify Product Quality
This article was originally published in The Pink Sheet Daily
Public meeting will solicit stakeholder comments on how FDASIA-mandated import regulations should be implemented as the expedited entry program reemerges.
You may also be interested in...
An initial look at data from the first year of the import screening system’s full operation finds PREDICT is effective in directing FDA inspectors to high-risk products, Deputy Associate Commissioner for Regulatory Affairs Steve Solomon says.
Batch failure and other measures commonly tracked by manufacturers could be aggregated into an industry-wide index that FDA would use to help make risk-based inspection decisions.
Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.