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ASQ Keynote February 13, 2006

A Look Back at 2006 The year of the hurricane Organizational Change National and District Changes in programs Adverse Drug Experience A Look at Today FDA celebrates 100 years Program changes

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ASQ Keynote February 13, 2006

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  1. A Look Back at 2006 The year of the hurricane Organizational Change National and District Changes in programs Adverse Drug Experience A Look at Today FDA celebrates 100 years Program changes Increase in Atlanta District high risk firms Resource Changes A Look ahead Budget Submission for 07 Resource necessitated changes ASQ KeynoteFebruary 13, 2006

  2. New Content & Format of Labeling for Human Rx Drugs and Biological Products • First revision in 25 years • Applicable for new and recently approved products • Specific graphical requirements and reorganization of critical information to enable physicians to find the information quickly

  3. New Content & Format of Labeling for Human Rx Drugs and Biological Products • Highlights: provides immediate access to the most important prescribing information about benefits and risks • Table of Contents: easy reference to detailed safety and efficacy information • Date of initial product approval making it easy to determine how long the product has been on the market • Toll-free number and Internet reportinginformation for suspected adverse events to encourage more widespread reporting of suspected side effects

  4. Top 10 Atlanta Turbo CitesDrugs, Devices, Biologics, BIMO

  5. Top 10 Atlanta Turbo CitesDrugs

  6. Top 10 Atlanta Turbo CitesTies for Number 10

  7. DRUG RECALLS – FY 05 • CLASS I - 17 • CLASS II - 316 • CLASS III - 169

  8. DRUG RECALL – FY 05 • Class 1 (11 Rx / 6 OTC) • Class II (267 Rx / 49 OTC) • Class III (123 Rx / 46 OTC)

  9. REASONS FOR RECALL • CGMP DEVIATIONS (144) • FAILED DISSOLUTION TEST REQUIREMENTS (57) • MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS (31) • LACK OF EFFICACY (25) • IMPURITIES/DEGRADATION PRODUCTS (19)

  10. REASONS FOR RECALL • LACK OF STERILITY ASSURANCE (18) • PRODUCT STABILITY (16) • LABELING ERROR/DECLARED STRENGTH (13) • MISBRANDED/PROMOTIONAL LITERATURE CLAIMS (13)

  11. TIE FOR TENTH • LABELING ISSUES (MISCARTONED OR MISPACKED (12) • SUBPOTENT – SINGLE INGREDIENT DRUG (12) • SUPERPOTENT –SINGLE INGREDIENT DRUG (12)

  12. HELP NEEDED • Check if sending to right District • Identify NDA/NDA/BLA number of application, firm name and name of drug on cover of file. Beware of paper clips • Name of District firm identified. • Fasteners/overfill • Contact for listing of active applications

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