1. Generic Industry’s Perspective on the New GMP Initiative May 21, 2003 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance TEVA Pharmaceuticals USA

2. Risk-Based Approach Definition –Implementation –Benefits Dialogue –Guidance

3. Changes to Approved Applications Interim Specifications Development Report: –Guidelines –How to be used –No Negative Impact on Review –Goals

4. Pre-Approval Inspections No longer universally necessary –Except Novel Compounds & New Technologies Chemistry Reviewer Inspections –No Delays

5. Communications 483 Dispute Resolution Publish Internal FDA polices and Procedures Publish Control Documents Proceduralize Pre-ANDA meetings

6. Summary – Guidance & Procedures GPhA welcomes the opportunity to work with FDA, industry and academia on developing the science to create the procedures to allow for a new regulatory framework.