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Titles
- E11(R1) addendum: clinical investigation of medicinal products in the pediatric population1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- E17 general principles for planning and design of multiregional clinical trials1
- E18 genomic sampling and management of genomic data1
- E6(R2) good clinical practice: integrated addendum to ICH E6(R1)1
- Elemental impurities in drug products1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1
- Enforcement policy for clinical electronic thermometers during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for Industry and Food and Drug Administration staff1
- Enforcement policy for extracorporeal membrane oxygenation and cardiopulmonary bypass devices during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for face masks and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and food and drug administration staff1
- Enforcement policy for gowns, other apparel, and gloves during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for infusion pumps and accessories during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff1
- Enforcement policy for remote ophthalmic assessment and monitoring devices during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for sterilizers, disinfectant devices, and air purifiers during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for ventilators and accessories and other respiratory devices during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff1
- Enforcement policy--OTC sunscreen drug products marketed without an approved application1
- Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization1
- Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)1