Manan Shah
Manan Shah is Senior Manager, Regulatory Affairs, G&L Healthcare Advisors, US.
JournalOverview of importation strategy from an FDA perspective – PLAIR vs FTZ
In the current landscape, pharmaceuticals and biologics are manufactured at global current good manufacturing practice facilities for distribution in the US market. The importation of these products is a crucial process, as it ensures that patients can access these products in a timely fashion upon approval of applications to health ...