Incomplete or inaccurate facility information on NDA/ANDA form 356h cover letters are causing decisions on conducting preapproval inspections (PAIs) to be delayed or tabled, FDA field managers are reporting.
The cover letter problem was highlighted by PAI managers at their September meeting at the agency’s White Oak headquarters in Maryland. FDA has been receiving about 110-140 NDAs per year with each referencing, on average, six to eight establishments. A little more than half are foreign facilities.
Addressing PAI issues at an Xavier University/FDA Global Outsourcing Conference in Cincinnati in early October, Cincinnati District Investigator and Drug Preapproval Manager Kathleen Culver focused heavily on the September discussions regarding deficiencies being found in NDA/ANDA cover letters and the impact it is having on inspection planning.
To find more information please click here: IPQ: Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections
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