Lecture 1 - 8/23/2011 Biologics Industry: A Regulatory...

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8/23/2011 1 David W. Mullis, Jr., Ph.D., RAC Resource: FDA’s Center for Biologics Evaluation and Research www.FDA.gov/BiologicsBloodVaccines/ Biologics Industry: A Regulatory Overview PHAR 6010 Overview 1. Introduction 2. Regulatory History 3. FDA – Center for Biologics Evaluation and Research 4. New Biologics Development and Review 5. IND 6. BLA 2
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8/23/2011 2 Biologic Product Definition • Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. • Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. • Biologics are isolated from a variety of natural sources – human, animal, or microorganism- and may be produced by biotechnology… 3 Biological Product: 21 CFR 600.3(h) • Means any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man • Biologics are substances derived from or made with the aid of living organisms 4
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8/23/2011 3 Regulatory History • Statutory Authority The Public Health Service Act The Food Drug and Cosmetic Act • Biologics are also Drugs Some portions do not apply 5 Origins of The Public Health Service Act Diptheria Outbreak-1890s Diptheria Antitoxin Treatment Horse Antiserum Horses injected with Diptheria toxin Horses were then bled Serum used to treat patients “A horse named Jim” 10 Children die from Tetanus in St. Louis 1902 Biologics Control Act Congress reacted to tragedy Establishment and product license Allowed promulgation of Biologics Regulations Established basis for inspections 6
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8/23/2011 4 Regulatory History • 1903-First Biologics Regulations Issued Administered by the Public Health Services Hygienic Laboratory Required Annual Establishment Licenses Formalized unannounced inspections Note: Pure Food & Drug Act was not passed until 1906 to all regulation of other drugs • 1919-Amendments to Biologics Regulations Manufacturers required to report changes in personnel, equipment and methods Required permanent records of manufacturing and quality 7 Regulatory History • 1938-Federal Food Drug and Cosmetic Act Added Safety Requirements Inspection Authority • 1944- Biologics Control Act Revised Made Part of the Public Health Service Act Division of Biologics Standards Transferred to FDA-1955 CBER is a Descendent of this Organization • 1955-Division of Biological Studies (NIH) NIH was Lead Agency until 1972 • 1988-Center for Biologics Evaluation and Research 8
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8/23/2011 5 Regulatory History • 1992-Prescription Drug User Fee Act (PDUFA) • 1997-Food and Drug Administration Modernization Act
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This note was uploaded on 01/01/2012 for the course PHRM 7230 taught by Professor Tackett during the Spring '11 term at University of Georgia Athens.

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Lecture 1 - 8/23/2011 Biologics Industry: A Regulatory...

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