Subjects: Government Regulation / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

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471. Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2023
Subject(s):: Device Approval
Government Regulation
Software -- legislation & jurisprudence
Software -- standards
Software Design
United States

472. Clinical drug interaction studies with combined oral contraceptives: guidance for industry

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

473. Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

474. 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

475. 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

476. 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

477. 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

478. 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

479. 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

480. 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

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