1. 1 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 Increase in Atlanta District high risk firms Resource Changes A Look ahead Budget Submission for 07 Resource necessitated changes

2. 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. 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 reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects

4. Top 10 Atlanta Turbo Cites Drugs, Devices, Biologics, BIMO CITE DESCRIPTIONCFR REFERENCE Documentation – general General 21 CFR 820.75(a) Investigations of discrepancies, failures 21 CFR 211.192 Quality Audits conducted 21 CFR 820.22 Cleaning/maintenance records not kept 21 CFR 211.67 (c) Procedures, finished devices 21 CFR 820. 80 (d) Management Responsibility 21 CFR 820.20 Maintained and followed 21 CFR 606.100 (b) Environmental Control21 CFR 870.70 (c) Scientifically sound laboratory controls 21 CFR 211.160 (b)

5. Top 10 Atlanta Turbo Cites Drugs CITE DESCRIPTIONCFR REFERENCE Investigations of discrepancies, failures21 CFR 211.192 Cleaning/maintenance records21 CFR 211.67 (c) Scientifically sound laboratory controls21 CFR 211.160 (b) GMP Training Frequency21 CFR 211.25 (a) Valid stability test methods21 CFR 211.166 (a) (3) Control procedures to monitor and validate performance 21 CFR 211.110 (a) Items to cover on annual reviews21 CFR 211.180 (e) (2) Second Person sign off21 CFR 211. 194 (a) (8) Yield calculations not verified by 2 nd person 21 CFR 211.103 Expired drugsFDCA 501(a)(5)

6. 6 Top 10 Atlanta Turbo Cites Ties for Number 10 CITE DESCRIPTIONCFR REFERENCE Tests Methods21 CFR 211.165(e) Failing drug products not rejected 21 CFR 211.165(f) Written program not followed21 CFR 211.166(a) Prepared for each batch, include complete information 21 CFR 211.188 Laboratory equipment calibration records 21 CFR 211.194(d)

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

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

9. 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. 10 REASONS FOR RECALL LACK OF STERILITY ASSURANCE (18) PRODUCT STABILITY (16) LABELING ERROR/DECLARED STRENGTH (13) MISBRANDED/PROMOTIONAL LITERATURE CLAIMS (13)

11. 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 drugon cover of file. Beware of paper clips  Name of District firm identified.  Fasteners/overfill  Contact for listing of active applications