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FDA Accelerates Inspection Process With New Concept Of Operations

 
• By Bowman Cox

'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.

Concept of bureaucracy with man paddling in a sea of sheets

Now that US FDA has aligned its facility and product review organizations, the agency is launching new workflows outlined in a "concept of operations" agreement to accelerate work in those organizations, the heads of facilities and drug review organizations told staff in an Aug. 21 email.

The agreement is at the heart of efforts to speed up facility reviews in line with product reviews, which have accelerated because of user fee commitments.

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