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FDA ADVISORY COMMITTEES

FDA ADVISORY COMMITTEES. Mary A Foulkes, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, FDA. FDA/Industry workshop Bethesda, MD September 19, 2003. CDER Cardio-Renal Drugs AntiInfective Drugs Antiviral Drugs Oncologic Drugs CBER

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FDA ADVISORY COMMITTEES

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  1. FDA ADVISORY COMMITTEES Mary A Foulkes, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, FDA FDA/Industry workshop Bethesda, MD September 19, 2003

  2. CDER Cardio-Renal Drugs AntiInfective Drugs Antiviral Drugs Oncologic Drugs CBER Blood & Blood Products Vaccines CVM Veterinary Meds CDRH Circulatory System Devices Dental Devices Radiologic Devices CFSAN Food Advisory NCTR Ranch Hand Range of Advisory Committees

  3. FACA • Federal Advisory Committee Act Public Law 92-463 • Independent advice on scientific issues • Enhance, compliment, speed decision-making • Provide forum for public input (advanced notice, public meetings) • http://www.gsa.gov/Portal/browse/channel.jsp?channelId=-13689

  4. FACA • Scientific – Not Policy • Advisory Only • One hour for public comment • Have Background material fr all sides 18 days prior to mtg (also webposted) • Limitations on Last-Minute Material

  5. INDEPENDENCE • Appointed by Commissioner • Fixed Terms • Screened for COI/Bias • Large Role Played by Chair

  6. Standing mbrs Scientific/Tech experts Statistician Consumer rep Industry rep Other invitees Patient rep Disease/condition experts Occasional Senators COMPOSITION

  7. Pre-Meeting IAs • Generally Limited – Discussion of Issues must be in public • Factual questions possible, but Exec Sec must be involved

  8. General Public FDA Reviewer Executive Secretary Committee Member Industry

  9. 8:00 am 8:15 8:30 10:00 10:15 11:45 1:00 pm 2:00 4:30 Administrative remarks FDA Introduction Sponsor’s Presentation Break FDA’s Presentation Lunch Open Public Hearing Committee Disc’n & Vote Adjourn TYPICAL AGENDA

  10. Questions to ACs • Were studies adequate to evaluate product effect? • Was population studied appropriate? • Is it appropriate to pool data? • Optimal correction methodology for QT correction? • Add’l pt safety monitoring advised? • If licensed, should the label describe any limitations in generalizing to certain subgroups?

  11. Issues for ACs • Discuss trial designs, incl f/up dur’n • Endpoints, esp surrogates • Measurement/quant’n (e.g. QT interval & mult correction meths) • Phase IV commitments • 1st year safety reviews of ped experience mandated by Best Pharmaceuticals for Children Act • Generalizability of results

  12. Perogative • ACs can reword or answer the question they wish had been asked • ACs often answer questions that were not asked, offering advice on future considerations • ACs often ask for more information, more data (e.g. cross-resistance), more studies (e.g. Phase IV)

  13. Statistician’s Responsibility • Know their subject • Know the process COMMUNICATE

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