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Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions

This draft guidance provides animal study recommendations  to support a 510(k) submission for dental bone grafting material devices. ....

Drug Administration , Radiological Health , Guidance Issuing Office , Submit Comments ,

Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples

Guidance for Industry - Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples, Generics ....

Guidance Issuing Office , Drug Administration , Submit Comments , Drug Evaluation ,