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Titles
- E11(R1) addendum: clinical investigation of medicinal products in the pediatric population1
- E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers1
- 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
- E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry1
- E6(R2) good clinical practice: integrated addendum to ICH E6(R1)1
- Early management of patients with a head injury: a national clinical guideline1
- Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff1
- Elemental impurities in drug products1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1
- Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff1
- 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 staff1
- 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 staff1
- Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff1
- Enforcement policy--OTC sunscreen drug products marketed without an approved application1
- Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry1
- Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders1
- Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff1