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241. Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Drug Evaluation, Preclinical
Drug Industry
Government Regulation
Pharmaceutical Preparations
Toxicity Tests
United States

242. Drug-drug interaction assessment for therapeutic proteins: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Cytokines
Drug Industry
Drug Interactions
Government Regulation
United States

243. Action level for inorganic arsenic in apple juice: guidance for industry

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, June 2023
Subject(s):: Arsenic
Food Safety
Food Supply
Government Regulation
United States

244. Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 26, 2023
Subject(s):: Device Approval
Government Regulation
Morcellation -- instrumentation
Morcellation -- legislation & jurisprudence
Morcellation -- standards
United States

245. Requirements for additional traceability records for certain foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, May 2023
Subject(s):: Food Industry
Food Labeling
Food Packaging
Food Safety
Food Supply
Government Regulation
Legislation, Food
United States

246. Implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
Subject(s):: Blood Donation
Blood Donors
Donor Selection
Government Regulation
Mandatory Testing
Surveys and Questionnaires
United States

247. Recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
Subject(s):: Blood Donation
Blood Donors
Blood Transfusion
Donor Selection
Government Regulation
HIV Infections -- prevention & control
Mandatory Testing
United States

248. Chronic rhinosinusitis with nasal polyps: developing drugs for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Nasal Polyps -- drug therapy
Sinusitis -- drug therapy
United States

249. Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Direct-to-Consumer Advertising -- legislation & jurisprudence
Direct-to-Consumer Advertising -- standards
Disclosure
Drug Industry
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
Government Regulation
United States

250. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
Subject(s):: Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States

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