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• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

  Tags Institutional Review Board (IRB), NSPS 1, NSPS 2, R-Res&Pub, Research, Research Design
  Creator: FDA
  Subject: Research
  Item Type: Hyperlink
  Date Last Updated: 2021-05
  Description: Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
  Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA…

• Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop

  Tags Ethics, Federal Research Partners, Informed Consent, Institutional Review Board (IRB), Patient Care, Prophylaxis, Public Health, R-Res&Pub, Therapeutics, Vaccine Study
  Creator: National Academies of Sciences, E. and Medicine
  Subject: Research
  Item Type: Publication
  Date Last Updated: 2017-10-31
  Description: During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to…