Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
Source: fda.gov
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Characterization of Metallic Coatings and/or Calcium Phosphate Coating
This document provides recommendations for premarket submissions for orthopedic devices that contain metallic and/or calcium phosphate coatings on the surface.
Source: fda.gov
Potency Assurance for Cellular and Gene Therapy Products
This is the Draft Guidance for Industry, Potency Assurance for Cellular and Gene Therapy Products
Source: fda.gov
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
This draft guidance provides FDA’s current thinking on the 510(k) Third Party Review Program and review of EUA requests by third party review organizations.
Source: fda.gov
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process
This guidance assists sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation of a new animal drug.
Source: fda.gov