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

Start Over Subjects Government Regulation ✖ Genre Technical Report ✖ Copyright Public domain ✖

81. Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 22, 2022
Subject(s):: Device Approval
Government Regulation
United States
United States. Food and Drug Administration

82. Q3D(R2) elemental impurities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Drug Contamination
Drug Industry
Elements
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration

83. Policy for monkeypox tests to address the public health emergency: guidance for laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 7, 2022
Subject(s):: Government Regulation
Monkeypox -- diagnosis
Monkeypox -- prevention & control
Public Health
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration

84. Submitting documents using real-world data and real-world evidence to FDA for drug and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration

85. Tobacco products: principles for designing and conducting tobacco product perception and intention studies

Publication:: Silver Spring, MD : Center for Tobacco Products, August 2022
Subject(s):: Evaluation Studies as Topic
Government Regulation
Methods
Tobacco Products
United States
United States. Food and Drug Administration

86. Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Diagnostic Test Approval
Government Regulation
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration

87. Regulatory requirements for hearing aid devices and personal sound amplification products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Device Approval
Government Regulation
Hearing Aids
United States
United States. Food and Drug Administration

88. Policy regarding N-acetyl-L-cysteine: guidance for industry

Publication:: College Park, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Acetylcysteine
Drug Industry
Government Regulation
United States
United States. Food and Drug Administration

89. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

90. Cancer clinical trial eligibility criteria: available therapy in non-curative settings

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
United States
United States. Food and Drug Administration

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