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Titles
- E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers1
- E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry1
- Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff1
- 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
- Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry1
- Evaluation of gastric pH-dependent drug interactions with acid-reducing agents: study design, data analysis, and clinical implications : guidance for industry1
- Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry1