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

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

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

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

7 DRUG RECALLS – FY 05 CLASS I - 17 CLASS II 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)

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