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211. 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

212. 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

213. 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

214. 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

215. 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

216. Informed consent. Guidance for IRBs, clinical investigators, and sponsors

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Ethics Committees, Research
Government Regulation
Informed Consent
Research Personnel
United States
United States. Food and Drug Administration

217. Waivers, exceptions, and exemptions from the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration
United States.

218. 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

219. CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):: Drug Industry
Government Regulation
Quality Control
Reference Standards
United States
United States. Food and Drug Administration

220. 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

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