中英文-FDA Regulatory Affairs1.1.docx

FDA Regulatory Affairs: A Guide for Prescription Drugs目录1、Overview of Drug Development and the FDA——Douglas J. Pisano药品发展和FDA概述1.1 Brief History of Drug Laws and RegulationsPrior to 1902, the U.S. government took a hands-off approach to the regulation of drugs. Many of the drugs available were so-called “patent medicines” which were so named because each had a more or less descriptive or patent name. No laws, regulations or standards existed to any noticeable extent even though the United States Pharmacopeia (USP) became a reality in 1820 as the first official compendium of the U.S. The USP set standards for strength and purity that could be used by physicians and pharmacists who needed centralized guidelines to extract, compound, and otherwise utilize drugcomponents that existed at the time.However, in 1848, the first American drug law, the Drug Importation Act,was enacted when American troops serving in Mexico became seriously affected when adulterated quinine, an antimalarial drug, was discovered.This law required laboratory inspection, detention, and even destruction of drugs that did not meet acceptable standards. Later, in 1902, the Virus, Serum and Toxins Act (Biologics Control Act) was passed in response to tetanusinfected diphtheria antitoxin which was manufactured by a small laboratory in St. Louis, MO. Thirteen school children died as a result of the tainted serum. No national standards were as yet in place for purity or potency.The Act authorized the Public Health Service to license and regulate the interstate sale of sera, vaccines, and related biologic products used to prevent or treat disease.This Act also spurred Dr. Harvey W. Wiley, chief chemist for the Bureau of Chemistry, a branch of the U.S. Department of Agriculture (USDA) and the forerunner for today’s U.S. Food and Drug Administration (FDA), to investigate the country’s foods and drugs. He established the Hygienic Table,a group of young men who volunteered to serve as human guinea pigs, and w