References
- Peterson LR, Jamieson DJ, Powers AM, et al. Zika virus. NEJM. 2016;374:1552–1563.
- Code of Federal Regulations 21 Part 601. 2016. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601&showFR=1&subpartNode=21:7.0.1.1.2.5
- Guidance for Industry - General Principles for the Development of Vaccines to Protect against Global Infectious Diseases. 2011 Dec. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM282995.pdf
- Guidance for Industry - Product Development Under the Animal Rule. 2015 Oct. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf
- Guidance for Industry - Expanded access to investigational drugs for treatment use – Question and answers. 2016 Jun. Available from: http://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf
- Guidance for Industry - Emergency use Authorization of Medical Products and Related Authorities. 2017 Jan. Available from: http://www.fda.gov/downloads/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/UCM493627.pdf