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Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

This document provides recommendations for premarket submissions for orthopedic devices that contain metallic and/or calcium phosphate coatings on the surface.

This is the Draft Guidance for Industry, Potency Assurance for Cellular and Gene Therapy Products

This draft guidance provides FDA’s current thinking on the 510(k) Third Party Review Program and review of EUA requests by third party review organizations.

This guidance assists sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation of a new animal drug.

This guidance document addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments, including expanded and new interpretations of policy.

This guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate labeling that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.

Select updates for the 506J Guidance: proposed list of devices requiring 506J notification and clarification as to the submission of voluntary notifications

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers

Diabetic Foot Infections: Developing Drugs for Treatment