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221. 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

223. 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

224. 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

227. 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

229. 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