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8472. 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

8473. 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

8476. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 27, 2023
Subject(s):
Contact Lens Solutions
Device Approval
Government Regulation
Hydrogen Peroxide
Product Labeling
United States
United States. Food and Drug Administration

8478. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):
Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration

8479. The financial stability of America’s hospitals and health systems is at risk as the costs of caring continue to rise

Publication:
[Washington, D.C.] : American Hospital Association, April 2023
Subject(s):
Economics, Hospital -- statistics & numerical data
Economics, Hospital -- trends
Hospital Costs -- statistics & numerical data
Hospital Costs -- trends
Equipment and Supplies, Hospital -- economics
Personnel, Hospital -- economics
United States