Drug Delivery

FDA softens iron stance

FDA softens iron stance

The US FDA has advised manufacturers of drugs and dietary
supplements containing 30mg or more of iron per dose that they are
no longer required, by law, to use unit-dose packaging

Closer EU/US ties

Closer EU/US ties

The EU and US move a small step closer to a harmonised regulatory
system with the first-ever collaboration on the review of
scientific data in an application to start a clinical trial.

GMP on the agenda

GMP on the agenda

Mixed news on GMP compliance, as Australia's API has its
manufacturing license renewed after a six-week suspension and GSK
unveils a US FDA probe.