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Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer's Goods from DWPE

This guidance is intended to provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens. ....

Office Of Food Safety , Guidance Issuing Office , Drug Administration , Division Of Seafood Safety , Submit Comments , Food Safety , Seafood Safety ,

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 ....

Health Equity , Drug Administration , Office Of Clinical , Office Of Women Health , Office Of Pediatric Therapeutics , Oncology Center , Office Of Minority Health , Radiological Health , Guidance Issuing Office , Submit Comments , Biologics Evaluation , Drug Evaluation , Minority Health , Clinical Policy , Ethnicity Data ,

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. ....

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

Potency Assurance for Cellular and Gene Therapy Products

This is the Draft Guidance for Industry, Potency Assurance for Cellular and Gene Therapy Products ....

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

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This draft guidance provides FDA’s current thinking on the 510(k) Third Party Review Program and review of EUA requests by third party review organizations.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

Guidance Issuing Office , Third Party Review Program , Drug Administration , Radiological Health , Submit Comments , Emergency Use Authorization , Preview Program ,