PhRMA Backs FDA Plan to Improve Distribution of Inspection Information

April 13, 2017

PhRMA has endorsed the FDA’s plan to release more timely inspection information relevant to drug product reviews.

Among those reviews not completed within the PDUFA-mandated timetable, nearly 88 percent missed the deadline due to late completion of GMP inspections.

In a comment on the FDA’s assessment of its program for enhanced review transparency and communication, PhRMA agreed with the agency that inconsistent communication and lack of information access slows review timelines, with only 46 percent of program applications receiving full inspections within program timetables.

PhRMA voiced support for the report’s recommendation that FDA examine its information dissemination procedures for inspection-related issues at all levels, including communication between offices, sponsors and review divisions.

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