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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
- Early challenges highlight areas for improvement in COVID-19 vaccination programs1
- Electronic health information exchange: use has increased, but is lower for small and rural providers : report to congressional requesters1
- Electronic health information: HHS needs to improve communications for breach reporting : report to congressional committees1
- Electronic health record modernization: VA needs to address change management challenges, user satisfaction, and system issues : testimony before the Committee on Veterans’ Affairs, U.S. Senate1
- Electronic health records: Additional DOD actions could improve cost and schedule estimating for new system : report to congressional committees1
- Electronic health records: Challenges with VA’s new system call for management improvements : testimony before the Subcommittee on Technology Modernization, Committee on Veterans’ Affairs, House of Representatives1
- Electronic health records: VA needs to address data management challenges for new system : report to congressional requesters1
- Electronic health records: VA needs to address management challenges with new system : report to congressional addressees1
- 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