FDA draft 'conditions established' guidance proposes to smooth the way for continual improvement of manufacturing processes for drugs and biologics by saying which manufacturing changes don't need to be reported.
Companies may be more likely to continually improve the way they make drugs and biologics now that FDA has clarified in a May 29 draft guidance that it will only review and inspect for changes to the conditions established in approved applications and licenses.
By defining such established conditions, the draft guidance clarifies which changes are so minor that companies should manage them with...
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