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- Adverse Event Reporting
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- FDA webpage: “What is a Serious Adverse Event?”
- Drug label changes per FDA-How to Receive Email Updates from About FDA Drug Label Changes
- FDA Guidance: Expanded Access to Drugs for Treatment Use (updated 2017)
- How to submit an Expanded Access Request (FDA)
- Individual Expanded Access Applications: Form 3926 (2017)
- 21 CFR 50-Informed Consent and Children
- 21 CFR 56- Institutional Review Boards
- 21 CFR 312-INDs
- 21 CFR 812- IDEs
- Emergency IND FDA Information Sheet
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