Copyright: Public domain / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

Start Over Copyright Public domain ✖ Dates by Range 2000 and later ✖

2001. Soft (hydrophilic) daily wear contact lenses: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Contact Lenses, Hydrophilic -- standards
Device Approval
Equipment Safety
Government Regulation
United States

2002. General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Animal Experimentation
Animal Welfare
Animals, Laboratory
Device Approval
Equipment Safety
Equipment and Supplies
Government Regulation
United States

2003. Transition plan for medical devices that fall within enforcement policies issued during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):: Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

2004. Transition plan for medical devices issued emergency use authorizations (EUAs) related to coronavirus disease 2019 (COVID-19): guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):: Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

2005. Enforcement policy for face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):: COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
Personal Protective Equipment
United States
United States. Food and Drug Administration

2006. Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):: COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
United States. Food and Drug Administration

2007. Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Drug Industry
Legislation, Drug
Drug Packaging
Drug and Narcotic Control
Government Regulation
United States

2008. Evaluation of gastric pH-dependent drug interactions with acid-reducing agents: study design, data analysis, and clinical implications : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Drug Industry
Drug Interactions
Gastrointestinal Agents
Government Regulation
Hydrogen-Ion Concentration
United States

2009. Q13 continuous manufacturing of drug substances and drug products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Biological Products
Drug Compounding
Drug Development
Drug Industry
Government Regulation
United States

2010. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):: Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

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