US FDA Urged To Rethink Warning Letters To Avoid ‘Collateral Damage’
Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance
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One of the faces of FDA's effort to recruit senior leaders from outside its walls has decided to return to industry.
US FDA's GDUFA II commitment to alert generics firms within 90 days regarding inspection results will put additional pressure on Form 483 responses, possibly starting later this year.