CDER Director Janet Woodcock, MD, and Melinda Plaisier, associate commissioner for regulatory affairs, sent an email to FDA staff Monday, saying the new plan is necessary for the agency to meet certain commitments outlined in the reauthorized user fee agreements. Starting October 2018, the agreements will require the agency to provide generic drugmakers with final inspection classifications within 90 days of inspection.
To streamline operations, the FDA developed specific operating models for planning and conducting various types of agency inspections, among other resources aimed to improve the inspection process.
The agency will enact the new models in fall 2017 for “nearly all human drugs,” Dr. Woodcock and Ms. Plaisier wrote in the email.
To view the full plan, click here.
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