FDA regulations set forth the "essentials of adequate and well-controlled clinical investigation," including requirements that the study design permits a valid comparison with a control (including, placebo, dose comparison, no treatment, active, and historical) to provide a quatitative assessment of ...
第L分章―根据由食品与药品管理局行政执行的某些其他法的规章(SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION) 1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT 1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL ...
第L分章―根据由食品与药品管理局行政执行的某些其他法的规章(SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION) 1210 根据《联邦进口乳法》的规章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT 1230 根据《联邦腐蚀性毒物法》的规章 REGULATIONS UNDER THE FEDERA...
概述:美国《联邦规章典集》(Code of Federal Regulations,CFR)第21篇“食品与药品”(Title 21―Food and Drugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部,为健康与人类服务部食品与药品管理局(Food and Drug Administration,Department of Health and Human Services)的...
1 一般强制执行规章 GENERAL ENFORCEMENT REGULATIONS 2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS 3 产品管辖权 PRODUCT JURISDICTION 5 组织ORGANIZATION 7 强制执行政策 ENFORCEMENT POLICY 10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES 11 电子化记录;电子化签名 ELECTRONIC RECORDS; ...
EPCS revises DEA’s regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically as well as receiving, dispensing and archiving electronic prescriptions. The electronic prescription application must incorporate a secure process for practitioner authenticatio...
FDA是美国食品药物管理局(U.S. Food and Drug Administration)的英文缩写,它是国际医疗审核权威机构,由美国国会即联邦政府授权,专门从事食品与药品管理的最高执法机关。FDA是一个由医生、律师、微生物学家、药理学家、化学家和统计学家等专业人士组成的致力于保护、促进和提高国民健康的政府卫生管制的监控机构。通过...
approximately 20 years to complete.Though there were numerous other federal laws and regulations that were passed throughout the 1970s, many were based on regulating the practice of medical professionals or were for the direct protection of consumers. For example, The Federal Controlled Substances ...
美国FDA是U.S. Food and Drug Administration（美国食品和药品管理局）的简称。FDA是美国政府在健康与人类服务部 (DHHS) 和公共卫生部 (PHS) 中设立的执行机构之一。作为一家科学管理机构，FDA的职责是确保美国本国生产或进口的食品、化妆品、药品、医疗器械、辐射电子产品等的安全。FDA是最早以保护消费...
For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are … HP&M’s...