FDA Promises Shorter, Quicker Drug GMP Warning Letters
This article was originally published in The Gold Sheet
No more discursive treatises, the agency promises. From now on, drug GMP warning letters are going to be short and to the point – and they're going to arrive much more quickly.
You may also be interested in...
'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.
Transparency linked to new device registration rules will provide new market analysis possibilities. Medtech Insight delved deeper into the benefits of the European Medical Device Nomenclature with two Italian executives who see its potential.
26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.