US FDA suggests annual reporting for low-risk manufacturing changes
This article was originally published in Scrip
The US Food and Drug Administration is proposing to relax its policy on the submission of supplementary applications for minor and incremental changes to drug sponsors' manufacturing processes and controls.
You may also be interested in...
As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.
The Saudi Food & Drug Authority looks at the number of individual case safety reports (ICSRs) submitted by a company, among other risk-based factors, when drawing up its list for routine pharmacovigilance inspections.