The Food and Drug Administration will implement a plan to streamline facility inspection and evaluation processes, which are conducted through the agency's Center for Drug Evaluation and Research and Office of Regulatory Affairs, according to Regulatory Focus.
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.
More articles on supply chain:
6 must-reads for supply chain leaders this week
FDA approves generic version of Cymbalta: 3 things to know
Centurion Labs recalls cold medicine over possible bacterial contamination