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Assessment of Extractables/Leachables Data in ANDA Submissions

FDA discusses common review issues encountered in ANDA applications on extractables/leachables studies, the kind of information FDA is looking for and how the FDA evaluates extractables/leachables data in ANDA applications.
Patricia Onyimba, MS
Branch Chief
Division of Liquid-Base Products I, OPQ | CDER

Kshitij (Kris) Patkar, PhD
Senior Pharmaceutical Quality Assessor
Office Pharmaceutical Manufacturing Assessment, OPQ | CDER

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