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Lecture 1 - Biologics Industry A Regulatory Overview David...

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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 The FD & C Act applies 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 Changed FD&C Act and PHS Act Required Harmonization of Drugs and Biologics Regulations Amended Section 351 of PHS Act to include BLA
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