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Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

Oct 29th, 2011

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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.

Culver provided a revealing look inside the decision-making process of an inspection manager and what firms need to do to help make the process smoother and avoid costly delays.

She also provided a brief update on other PAI initiatives, including a Pharmaceutical Inspectorate pilot program on high-risk drugs and guidances the agency is developing on contract manufacturing and on PAI business processes and administrative policies.

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