director of Scientific Writing and Regulatory Affairs at Sciformix Corporation
FDA’s Proposed Generic-Drug Labeling Rule: Ensuring Efficiency and Compliance
If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.
Implementing FDA’s Electronic Labeling Proposal
Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.