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Showing results 1 - 20 of 20 for test.
Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors: Guidance for Industry | Guidance Portal
Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared...Bloodborne Pathogen Assays Used to Test Donors: Guidance for Industry Download
https://www.hhs.gov/guidance/document/revised-recommendations-regarding-invalidation-test-results-licensed-and-510k-cleared
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs | Guidance Portal
Return to Search In Vitro Permeation Test Studies for Topical Drug Products Submitted
https://www.hhs.gov/guidance/document/vitro-permeation-test-studies-topical-drug-products-submitted-andas
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs | Guidance Portal
Return to Search In Vitro Release Test Studies for Topical Drug Products Submitted
https://www.hhs.gov/guidance/document/vitro-release-test-studies-topical-drug-products-submitted-andas
“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV: Guidance for Industry | Guidance Portal
Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification...Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV:
https://www.hhs.gov/guidance/document/lookback-hepatitis-c-virus-hcv-product-quarantine-consignee-notification-further-testing
Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection: Guidance for Industry | Guidance Portal
Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg)
https://www.hhs.gov/guidance/document/requalification-method-reentry-donors-who-test-hepatitis-b-surface-antigen-hbsag-positive
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals | Guidance Portal
Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals Download the Guidance
https://www.hhs.gov/guidance/document/s2a-specific-aspects-regulatory-genotoxicity-tests-pharmaceuticals
Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry | Guidance Portal
Return to Search Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for
https://www.hhs.gov/guidance/document/pyrogen-and-endotoxins-testing-questions-and-answers-guidance-industry
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for Industry | Guidance Portal
Return to Search Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus...(HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral
https://www.hhs.gov/guidance/document/nucleic-acid-testing-nat-human-immunodeficiency-virus-type-1-hiv-1-and-hepatitis-c-virus
Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests: Guidance for Industry | Guidance Portal
...(HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled...Pooled Specimens or Diagnostic Tests: Guidance for Industry Download the Guidance
https://www.hhs.gov/guidance/document/certain-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-recovered-donors
On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test: Guidance for Industry | Guidance Portal
Allergenic Extract or Allergen Patch Test: Guidance for Industry Download the
https://www.hhs.gov/guidance/document/content-and-format-chemistry-manufacturing-and-controls-information-and-establishment-1
Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff | Guidance Portal
...to Search Non-Clinical Engineering Tests and Recommended Labeling for Intravascular
https://www.hhs.gov/guidance/document/non-clinical-engineering-tests-and-recommended-labeling-intravascular-stents-and
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry | Guidance Portal
Preventable Diseases: Production, Testing and Clinical Studies: Guidance for
https://www.hhs.gov/guidance/document/guidance-industry-evaluation-combination-vaccines-preventable-diseases-production-testing
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff | Guidance Portal
Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals
https://www.hhs.gov/guidance/document/premarket-notification-510k-submissions-testing-skin-sensitization-chemicals-natural
CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2) | Guidance Portal
Drugs in Human Food: Genotoxicity Testing (Revision 2) Download the Guidance
https://www.hhs.gov/guidance/document/cvm-gfi-116-vich-gl23-r2-studies-evaluate-safety-residues-veterinary-drugs-human-food
CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1) | Guidance Portal
Drugs in Human Food: Reproduction Testing (Revision 1) Download the Guidance
https://www.hhs.gov/guidance/document/cvm-gfi-115-vich-gl22-studies-evaluate-safety-residues-veterinary-drugs-human-food
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol | Guidance Portal
Return to Search Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated
https://www.hhs.gov/guidance/document/testing-glycerin-propylene-glycol-maltitol-solution-hydrogenated-starch-hydrolysate
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff | Guidance Portal
...medical devices - Part 1: Evaluation and testing within a risk management process"
https://www.hhs.gov/guidance/document/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1
Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry | Guidance Portal
Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from
https://www.hhs.gov/guidance/document/recommendations-obtaining-labeling-claim-communicable-disease-donor-screening-tests-using
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for… | Guidance Portal
Return to Search Use of Nucleic Acid Tests on Pooled and Individual Samples from
https://www.hhs.gov/guidance/document/use-nucleic-acid-tests-pooled-and-individual-samples-donors-whole-blood-and-blood-0
Outreach and Education AI/AN All Tribes Calls and Webinars | Guidance Portal
...that CMS will support state efforts to test incentives that make participation in...the Diabetes Prevention Program model test met the statutory criteria for expansion
https://www.hhs.gov/guidance/document/outreach-and-education-aian-all-tribes-calls-and-webinars