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== See also == {{Portal bar|Food|United States|Law|Medicine}} * [[Adverse reaction]] * [[Adverse event]] * [[Adverse drug reaction]] * [[Biosecurity]] * [[Biosecurity in the United States]] * [[Drug Efficacy Study Implementation]] * [[Food and Drug Administration Modernization Act of 1997]] * [[FDA Food Safety Modernization Act|FDA Food Safety Modernization Act of 2011]] * [[FDA Fast Track Development Program]] (for drugs) * [[Food and Drug Administration Amendments Act of 2007]] (e.g. drugs) * [[Food and Drug Administration Safety and Innovation Act|Food and Drug Administration Safety and Innovation Act of 2012]] (GAIN/QIDP etc.) * [[Inverse benefit law]] * [[Investigational Device Exemption]] (for use in clinical trials) * [[Kefauver Harris Amendment]] 1962 β required "proof-of-efficacy" for drugs '''International:''' * [[Food Administration]] * [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH) * African Union: [[African Medicines Agency]] * Australia: [[Therapeutic Goods Administration]] * Brazil: [[National Health Surveillance Agency]] * Canada: [[Marketed Health Products Directorate]] * Canada: [[Health Canada]] * Denmark: [[Danish Medicines Agency]] * European Union: [[European Medicines Agency]] * Germany: [[Federal Institute for Drugs and Medical Devices]] * India: [[Food Safety and Standards Authority of India]] * India: [[Central Drugs Standard Control Organization]] * Japan: [[Ministry of Health, Labour and Welfare]] (MHLW) * Japan: [[Pharmaceuticals and Medical Devices Agency]] * Mexico: [[Federal Commission for the Protection against Sanitary Risk]] * Philippines: [[Food and Drug Administration (Philippines)|Food and Drug Administration]] (FDA) * Singapore: [[Health Sciences Authority]] * United Kingdom: [[Medicines and Healthcare products Regulatory Agency]] * United States: Food and Drug Administration
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