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FDA Critical Path Initiative: A Generic Industry Perspective

FDA Critical Path Initiative: A Generic Industry Perspective. Shahid Ahmed American Pharmaceutical Partners on Behalf of the Generic Pharmaceutical Association. Outline. Overview of Generic Industry Critical Path Initiative Concepts Relevance to the Generic Industry

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FDA Critical Path Initiative: A Generic Industry Perspective

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  1. FDA Critical Path Initiative:A Generic Industry Perspective Shahid Ahmed American Pharmaceutical Partners on Behalf of the Generic Pharmaceutical Association

  2. Outline • Overview of Generic Industry • Critical Path Initiative Concepts • Relevance to the Generic Industry • Benefits of a Critical Path Initiative for the Generic Industry

  3. Overview of Generic Industry • Important component of the U.S. healthcare system • Generic drugs comprise 51% of the prescriptions dispensed in the US • Generic Drugs = 8% of overall cost of prescription drugs • Several off-patent Innovator products have no generic competition due to lack of guidance on requirements/or delays in such guidance, for example, steroid based Inhalers

  4. Critical Path Initiative Concepts • Improved tools for evaluating: • Safety • Medical utility/efficacy • Characterization and manufacturing • FDA expressed innovative thinking • Provides opportunity to accelerate ground breaking research and development

  5. Critical Path Initiative Concepts • Promotes enhanced collaboration among FDA, industry, academics, patient groups, etc. • Desired outcome: Opportunity for faster, more predictable and less costly pathway for drug development.

  6. Relevance to the Pharmacutical Industry • Primary emphasis on streamlining of drug discovery process • Improve evaluation methods for safety and efficacy outcomes • Increased utilization of FDA expertise and ‘best practices’ experience • Enhanced communication between FDA and industry

  7. Benefits of a Critical Path Initiative for the Generic Industry • Encourage FDA to continue its innovative outlook and develop a Critical Path Initiative focused on key problems related to generic drug development

  8. Benefits of a Critical Path Initiative for the Generic Industry • Consider early development of pathways for complex products to assist OGD and industry • MDI’s • Complex drug products • Protein products • Other • GPhA looks forward to collaboration on a Critical Path Initiative focused on unique challenges of the generic industry

  9. Benefits of a Critical Path Initiative for the Generic Industry • Collaboration with FDA and the Advisory Committee for Pharmaceutical Science can be a key component in addressing these challenges

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