FDA Preapproval Inspections Enhanced by New Guidance, Reviewer Participation

Increased reviewer engagement with investigators is impacting the preapproval inspection (PAI) process and helping FDA address the growing complexity of products and processes it faces in reviewing new drug applications (NDAs) and their supplements (sNDAs).

Agency reviewers are helping investigators get better prepared for what they will face and what they should look for during their PAIs and are directly participating in an increasing number of the inspections.

At the just-completed ISPE annual meeting in Orlando, Florida, Office of New Drug Quality Assessment (ONDQA) Science and Policy Deputy Director Christine Moore joined CDER compliance official Tara Gooen and drug investigator Ernie Bizjak at a “regulatory town hall forum” to offer the viewpoints of the review, compliance and field offices on “current and emerging issues” related to preapproval inspections and the impact of the new quality paradigm on the way the offices interrelate.

Moore discussed the increase in reviewer participation on PAIs, the value added to the review and inspection process, and how QbD submissions and product complexities are driving a more integrated review/inspection approach.

[More on the reviewer/investigator integration process and its impact on PAIs is provided for subscribers here.  The US and European dialogue around the growing importance of the reviewer/investigator relationship is explored in the IPQ May Special Report on implementing the ICH Q8-10/QbD paradigm.  Click here to subscribe.]