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Showing results 1 - 20 of 26 for test.
Redbook 2000: IV.C.1.d. Mammalian Erythrocyte Micronucleus Test | Guidance Portal
Mammalian Erythrocyte Micronucleus Test Issued by: Food and Drug Administration
https://www.hhs.gov/guidance/document/redbook-2000-ivc1d-mammalian-erythrocyte-micronucleus-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
Redbook 2000: IV.C.1.b. In vitro Mammalian Chromosomal Aberration Test | Guidance Portal
...vitro Mammalian Chromosomal Aberration Test Issued by: Food and Drug Administration
https://www.hhs.gov/guidance/document/redbook-2000-ivc1b-vitro-mammalian-chromosomal-aberration-test
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
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
Pyrogen and Endotoxins Testing: Questions and Answers | Guidance Portal
Return to Search Pyrogen and Endotoxins Testing: Questions and Answers Download the
https://www.hhs.gov/guidance/document/pyrogen-and-endotoxins-testing-questions-and-answers
“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
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
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
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers | Guidance Portal
...for Industry: Pyrogen and Endotoxins Testing: Questions and Answers Issued by:
https://www.hhs.gov/guidance/document/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers
Redbook 2000: IV.C.1. Short-Term Tests for Genetic Toxicity | Guidance Portal
Search Redbook 2000: IV.C.1. Short-Term Tests for Genetic Toxicity Issued by: Food
https://www.hhs.gov/guidance/document/redbook-2000-ivc1-short-term-tests-genetic-toxicity
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
CPG Sec. 254.100 Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis (Obsolete, Withdrawn on 11/28/2017) | Guidance Portal
Found to be Reactive to a Serologic Test for Syphilis (Obsolete, Withdrawn on
https://www.hhs.gov/guidance/document/cpg-sec-254100-source-plasma-use-units-donors-subsequently-found-be-reactive-serologic
CPG Sec. 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors (Obsolete, Withdrawn on 11/28/2017) | Guidance Portal
Search CPG Sec. 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis
https://www.hhs.gov/guidance/document/cpg-sec-255100-quantitative-testing-serum-proteins-plasmapheresis-donors-obsolete
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
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
CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1) | Guidance Portal
Human Food: Reproduction Toxicity 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
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