Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements
This guidance provides recommendations to industry on Master Files for new dietary ingredient notifications (NDINs).
Source: fda.gov
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Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
Source: fda.gov
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This draft guidance provides animal study recommendations to support a 510(k) submission for dental bone grafting material devices.
Source: fda.gov
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
Source: fda.gov
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
Source: fda.gov