Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 1 Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research Introductory Remarks

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 2 Accomplishments of Committee in the Last Three Years Provided input into food effect guidance Provided input on Biopharmaceutical Classification System (BCS) Helped in establishing Process Analytical Technologies (PAT) subcommittee

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 3 Accomplishments (cont.) Discussed dermatopharmacokinetics (DPK) and helped in making decision to withdraw draft guidance and focus on more general bioequivalence methodology for topicals Discussed PQRI project on blend uniformity assisting OPS in determining acceptability of recommendations

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 4 Debated individual bioequivalence and replicate design and provided OPS with feedback that served as background for making changes to General BA/BE Guidance Orally Inhaled and Nasal Drug Products (OINDP) - recommendations for BA/BE and chemistry guidances Accomplishments (cont.)

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 5 Accomplishments (cont.) Participated in awareness sessions on the following topics: –lactation –polymorphism –liposomes –risk based CMC review

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 6 Current Subcommittees PAT OINDP NCSS

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 7 Vision for Subcommittee Structure of ACPS ACPS Manu- facturing Clinical Pharm Pharm/ Tox Micro- biology Biopharm PAT NCSSOINDP

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 8 Future Focus GMP Initiative - includes manufacturing practices and policies CBER/CDER Consolidation Developing policies and practices to regulate new products, new delivery systems, etc.

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 9 Development and revision of new standards/guidances Focus on generic products - developing bioequivalence methods, etc. Evaluation of future PQRI recommendations Future Focus (cont.)

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 10 Changes in Membership Last Meeting: –Dr. Lee –Dr. Anderson –Dr. Berg –Dr. Doull –Dr. Boehlert –Dr. Jusko Sabbatical: –Dr. Venitz

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