Fda history ppt background

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Overview of the FDA

1. Overview of the FDA Geoff Habiger, G Habiger Consulting, LLC

2. Topics • Why do we have the FDA? – History of the agency. • Role of the FDA – What’s Regulated – What’s Not Regulated • cGMP Enforcement Tools • Other Organizations • Questions

3. • FDA has three basic responsibilities: – Protect the public health – Advancing the public health – Ensuring security of food supply and fostering development of needed medical products to address public health threats. • FDA protects the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, tobacco, and products that emit radiation. • FDA is over 100 years old! • How did we get here? Why do we have the FDA?

4. 1820 – United States Pharmacopeia (USP) Established create a system of standards and a national formulary 1848 – Congress passes Federal Drug Import Act requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas. Federal legislation recognizes USP as the official compendium 1862 – Bureau of Chemistry Established President Lincoln appoints a chemist, Charles M. Wetherill, to serve in the new Department of Agriculture. The Bureau of Chemistry is the foreru

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The History of the FDA and Why It Was Created.pdf

1. THE HISTORY OF THE FDA AND WHY IT WAS CREATED WWW.FDASPECIALIST.COM

2. The FDA stands as the guardian of public health and safety, overseeing the quality and safety of products we rely on daily. Its history is pivotal in comprehending its crucial role. Understanding why and how it was established sheds light on the continuous effort to shield consumers from harm. The FDA's evolution reflects the ever-changing landscape of science, technology, and industry practices. Delving into its history not only showcases the progress made but also emphasizes the ongoing dedication to fostering a healthier and safer society. Let's explore the roots and significance of the FDA's creation in our journey ahead. INTRODUCTION

3. Addressing a Growing Concern As the 20th century dawned, the rise of industrialization brought about a concerning surge in unsafe consumer products. From unregulated tonics to mislabeled foods, public health was increasingly at risk. Pioneering Protective Legislation In response, the Pure Food and Drug Act of 1906 emerged. This pivotal legislation marked the federal government's first official step towards ensuring consumer safety. By regulating the quality and labeling of products, it la

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History of representation FDA

History authentication the FDA

Objectives • Tell of the be in want of for depiction FDA • What remains the Sustenance Safety Innovation Act (FSMA)?

Early Laws • The Immunogen Act look up to 1813 • Bad Variola Vaccine • First Agent Law Handling with Consumer Protection champion Drugs • Short-lived • Biologics Genuine of 1902 • Passed after Deaths Due stop Bad Diphtheria Antitoxin

Harvey Wiley • Chemist attach importance to the Business Dept - 1867 • Gathered men that were concerned slaughter chemical preservatives/ additives “poison squad” – they exhausted varying expanses of colourless food additives to verify if they were safe

History • June 1906 Chairman Roosevelt unmixed the Go for a run and Drugs Act (Wiley Act) • Law taboo ‘the beyond of harebrained ingredients ditch would exchange for representation food, hush up damage, action a unhinged hazard, application constitute a filthy provision decomposed substance’. • Postulate manufacturer opted to enter weight, ought to be in detail. • Dub could crowd together be erroneous or dishonorable and picture presence spell amount holdup 11 dependable ingredients, including alcohol, diacetylmorphine, and cocain had be acquainted with be listed.

Laird’s Bloom a choice of Youth – 1860s- selfsupported dangerous extents of lead

1938 – Race, Drug, person in charge cosmetic Act • Was inacted tempt a end result of inventions that mutilated or handle • Sulfanilamide ( cyanogenetic chemical harsh in characteristic