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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
- E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification1
- E8(R1) general considerations for clinical studies1
- Early changes in waivered clinicians and utilization of buprenorphine for opioid use disorder after implementation of the 2021 HHS Buprenorphine Practice Guidelines1
- Economic effects of five illustrative single-payer health care systems1
- Electromagnetic compatibility (EMC) of medical devices: guidance for industry and Food and Drug Administration staff1
- Electronic health information: HHS needs to improve communications for breach reporting : report to congressional committees1
- Electronic health records: Additional DOD actions could improve cost and schedule estimating for new system : report to congressional committees1
- Electronic health records: VA needs to address data management challenges for new system : report to congressional requesters1
- Electronic prescribing of controlled substances among office-based physicians: 2017-20191
- Electronic public health reporting & recording of social & behavioral determinants of health among office-based physicians: 20191
- Electronic public health reporting among non-federal acute care hospitals during the COVID-19 pandemic, 20211
- Electronic submission of IND safety reports: technical conformance guide1
- Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff1
- Enhancing data infrastructure to improve women’s health outcomes1
- 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
- Expanding access to obesity treatments for older adults1
- Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics1