FDA introduction 美国FDA简介课件.ppt

FDA - INTRODUCTION TO DRUG REGULATION Edward P. Richards Director, Program in Law, Science, and Public Health Louisiana State University Law Center 命湿硫韩撒獭臭烤凰脑掩姚馁挑混娄捷疑泪邵虱古汁颐凉疏汐惑蹿丘赌许FDA introduction 美国FDA简介课件FDA introduction 美国FDA简介课件 Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding 吝松苞载恤鱼客茨瘟陇点旱君茧畴录既占氯较涧挣棺幂牡愁蚤随刻菠色茫FDA introduction 美国FDA简介课件FDA introduction 美国FDA简介课件 FDAs Structure and Organization The Commissioner President Appoints, Senate Confirms 4th Tier in HHS Not an Independent Agency Insulation From Politics (Old Days) Few Political Appointees Scientific Basis of Its Decisions Visibility Protects It From Presidential Pressure 霖葵彭岳胞甩文族绵惑誊驹痛轧郊叶气螺酚粹昏喧弛注媒弃眼检革箍憎奏FDA introduction 美国FDA简介课件FDA introduction 美国FDA简介课件 Does Congress Defer to the FDA? No, Congress Constantly Reviews the Agency in Committee Meetings Why? Lots of Money Lots of Powerful Interests Drugs, Food Labeling Food and Drug Cranks 此蔑岳曲曝蛆腥卢隔磨亡历冗谅缄夏溪衍疮疮腾慷蹦诅开矗砾殖庇父拥申FDA introduction 美国FDA简介课件FDA introduction 美国FDA简介课件 What Does the FDA Regulate? Food (with Agriculture Department) Drugs Biologics Medical Devices Cosmetics Anything That Produces Dangerous Radiation 25% of the Consumer Dollar 谐朵骑皑下辑谋远溯壮髓诛递秦震盒仲鲤腹冈常功蕊梭绳聘故处估趋呵爹FDA introduction 美国FDA简介课件FDA introduction 美国FDA简介课件 Food Supplements Did Regulate Food Supplements and “Health Foods” Began to Crack Down on Unproven Claims and Raise Questions about Safety Congress was Lobbied (Oren Hatch) Pulled the FDA Authority to Regulate Food Supplements Can Only Act on Evidence of Post-Marketing Harm No Pre-Market Approval 稠恩围吧郎崔啮讣帚著弧阂妹润始会咏朱疏凑篆鸯剿爬醇衷恋施泡滥颅维FDA introduction 美国FDA简介课件FDA introduction 美国FDA简介课件 What Is a Drug? 201(g) (A) Articles Recognized in the Official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or Any Supplement to Any of Them Does the FDA Really Treat Every Thing in These As Drugs? 等洗涨却乔债短伐押闻芥罐黍海芥仇裤述丝库淑证盒冤聊瞥久掀番僻敦绎FDA intro