References
- U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Providing Clinical Evidence of Efficacy for Human Drug and Biological Products. FDA, Rockville, MD, USA (1998).
- Novak JM, Barrett, J, McVittie LD et al. The Biological IND. In: Biologics Development: A Regulatory Overview. 2nd Edition. Mathieu M (Ed.). PAREXEL, Waltham, MA, USA, 49–81 (1997).
- Baylor NW, Midthun K. Regulation and testing of vaccines. In: Vaccines. Fifth Edition. Plotkin SA, Orenstein WA, Offit PA (Eds). Saunders Elsevier Inc., Philadelphia, PA, USA, 1618–1620 (2008).
- U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Postmarketing Studies and Clinical Trials – Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act. FDA, Rockville, MD, USA (2009).
Websites
- FDA §262 Regulation of Biological Products www.fda.gov/RegulatoryInformation/Legislation/ucm149278.htm
- Federal Food, Drug, and Cosmetic Act (FD&C Act) www.fda.gov/opacom/laws/fdcact/fdcact5a.htm
- Food and Drug Administration Amendments Act (2007) www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugand CosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration AmendmentsActof2007/FullTextof FDAAALaw/default.htm
- Prescription Drug User Fee Act (PDUFA) IV (2007) www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm145390.htm
- Code of Federal Regulations 21 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
- Code of Federal Regulations 21 Part 600 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=600
- Code of Federal Regulations 21 part 312 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312
- Code of Federal Regulations 21 § 312.21 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.21
- Code of Federal Regulations 21 Part 210 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210
- Code of Federal Regulations 21 Part 211 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
- Code of Federal Regulations 21 § 601.12 (2010) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=601.12&SearchTerm=license
- Vaccine Adverse Event Reporting System http://vaers.hhs.gov/about/index
- Pediatric Research Equity Act (2003) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ155.108
- U.S. Food and Drug Administration Pediatric Advisory Committee www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Pediatric AdvisoryCommittee/default.htm
- Pediatrics – US Food and Drug Administration www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeutics Research/default.htm
- US Department of Health and Human Services, National Vaccine Program Office www.hhs.gov/nvpo/index.html
- US Department of Health and Human Services, Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices www.cdc.gov/vaccines/recs/acip/default.htm
- US Department of Health and Human Services, Health Resources and Services Administration, National Vaccine Injury Compensation Program (VICP) www.hrsa.gov/vaccinecompensation
- CFR – code of federal regulations Title 21 www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm