The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply,...
Drug manufacturers having troubles complying with the FDA?s current
Good Manufacturing Practice (cGMP) regulations, may now have the
help they need thanks to a new white paper available on the
Drug manufacturers can better understand how they can achieve
regulatory compliance and avoid production stoppages and recalls by
following new guidance issued by the US Food and Drug
The US Food and Drug Administration will start using a risk-based
approach for prioritising site inspections for certain
pharmaceutical products, the agency has announced in a final report
on its current good manufacturing practice...