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Food and Drug Administration Safety and Innovation Act : ウィキペディア英語版 | The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.==Synthetic Drug Abuse Prevention==The law also contains the Synthetic Drug Abuse Prevention Act of 2012. The legislation bans synthetic compounds commonly found in synthetic marijuana ("K2"Vashi, Sonam (September 26, 2012). (K2 Trend Not Slowing Down ) WebMD Medical News via KOKI-TV or "Spice"),synthetic stimulants ("bath salts"Marder, Jenny (September 20, 2012). (Bath Salts: The Drug That Never Lets Go. ) ''PBS NewsHour''), and hallucinogens, by placing them under Schedule I of the Controlled Substances Act.===Generating Antibiotic Incentives Now=== Under TITLE VIII — GENERATING ANTIBIOTIC INCENTIVES NOW (GAIN) sections 801,802,803 provide designated candidate antibiotics : extension of exclusivity, priority review, fast track approval. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development. ==Synthetic Drug Abuse Prevention==
The law also contains the Synthetic Drug Abuse Prevention Act of 2012. The legislation bans synthetic compounds commonly found in synthetic marijuana ("K2"〔Vashi, Sonam (September 26, 2012). (K2 Trend Not Slowing Down ) WebMD Medical News via KOKI-TV〕 or "Spice"), synthetic stimulants ("bath salts"〔Marder, Jenny (September 20, 2012). (Bath Salts: The Drug That Never Lets Go. ) ''PBS NewsHour''〕), and hallucinogens, by placing them under Schedule I of the Controlled Substances Act. ===Generating Antibiotic Incentives Now=== Under TITLE VIII — GENERATING ANTIBIOTIC INCENTIVES NOW (GAIN) sections 801,802,803 provide designated candidate antibiotics : extension of exclusivity, priority review, fast track approval.
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.==Synthetic Drug Abuse Prevention==The law also contains the Synthetic Drug Abuse Prevention Act of 2012. The legislation bans synthetic compounds commonly found in synthetic marijuana ("K2"Vashi, Sonam (September 26, 2012). (K2 Trend Not Slowing Down ) WebMD Medical News via KOKI-TV or "Spice"),synthetic stimulants ("bath salts"Marder, Jenny (September 20, 2012). (Bath Salts: The Drug That Never Lets Go. ) ''PBS NewsHour''), and hallucinogens, by placing them under Schedule I of the Controlled Substances Act.===Generating Antibiotic Incentives Now=== Under TITLE VIII — GENERATING ANTIBIOTIC INCENTIVES NOW (GAIN) sections 801,802,803 provide designated candidate antibiotics : extension of exclusivity, priority review, fast track approval.」の詳細全文を読む
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