botanical

  • unique nature of botanical drugs
  • regulatory policies differ from those for synthetic, semi-synthetic, chemically modified drugs
  • OTC, IND, NDA requirements provided
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458484.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

rare diseasesRARE DISEASE  affects < 200,000 persons in US; most  affect far fewer persons. Guidance addresses  important aspects of drug development:

  • Disease’s natural history
  • Pathophysiology of disease and drug’s proposed mechanism of action
  •  Nonclinical pharmacotoxicology considerations
  • Reliable endpoints and outcome assessment
  • Standard of evidence to establish safety and effectiveness
  • Drug manufacturing considerations during drug development
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458485.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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