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ACPS, October 22, 2003 Advisory Committee for Pharmaceutical Sciences (ACPS) October 22, 2003 Pharmaceutical NomenclatureIssues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee for Pharmaceutical Sciences (ACPS) October 22, 2003 Pharmaceutical Nomenclature Issues and challenges FDA Perspective Orally Disintegrating Tablets (ODT) Topical Dosage Form Classification - an Update Committee Discussions Issues and challenges Impact on regulatory decisions, marketing, drug development, and the public Nomenclature development (scientific and regulatory challenges) How to do it right the first time? Is a new dosage form needed or is it just a minor modification in an existing dosage form that can be handled by labeling? How to establish definitions and criteria for new dosage forms? Do we need to have that many dosage forms? Issues and challenges Coordination with different organizations and stakeholders Definitions (descriptive and quantifiable attributes) Refinement and/or replacement of older dosage forms Pharmaceutical equivalence issues Questions for ACPS 1. What are the factors that the Agency should consider in determining (a) whether a new dosage form name is warranted and (b) how such a dosage form should be defined? 2. Is it reasonable or useful to include a quantifiable attribute when defining a dosage form or distinguishing between closely related dosage forms where appropriate? Can such an approach be viewed as too arbitrary in some cases and too rigid in other cases? Questions for ACPS 3. Is the proposed criterion, i.e., an in vitro disintegration time of less than 60 seconds, reasonable for defining an orally disintegrating tablet? 4. Has the update on topical dosage forms presented today addressed the questions/comments raised by the ACPS at the March 2003 meeting? FDA Perspective on Dosage Form Nomenclature Dr. Dan Boring, R.Ph., Ph.D. Review Chemist; Labeling Expert OND