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Titles
- Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry2
- Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)2
- Administrative rulemaking1
- Alternative procedures for blood and blood components during the COVID-19 public health emergency1
- Challenges to public health reporting experienced by non-federal acute care hospitals: 20191
- 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 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 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
- Policy for the temporary use of portable cryogenic containers not in compliance with 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 public health emergency1
- Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency1
- Statistical considerations for clinical trials during the COVID-19 public health emergency1
- Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: guidance for industry and Food and Drug Administration staff1
- Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency (revised)1
- Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)1
- Temporary policy for manufacture of alcohol for incorporation into alcohol-based hand sanitizer products during the public health emergency (COVID-19)1
- Temporary policy on Prescription Drug Marketing Act requirements for distribution of drug samples during the COVID-19 public health emergency1
- Temporary policy on repackaging or combining propofol drug products during the COVID-19 public health emergency1
- Temporary policy regarding accredited third-party certification program onsite observation and certificate duration requirements during the COVID-19 public health emergency1