Скачать или смотреть FDA Generic Drugs Science Workshop 2025: Welcome, Opening Remarks, and Program Overview

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This live presentation session at the Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop convenes to gather essential stakeholder input for the next fiscal year's generic drug science and research priorities. Speakers from the FDA's Office of Generic Drugs and Office of Pharmaceutical Quality underscore the agency's commitment to enhancing the availability of high-quality, safe, effective, and affordable generic drugs. The Generic Drug User Fee Amendments (GDUFA) science and research program is central to this mission, working to reduce regulatory barriers, foster competition, and ensure that bioequivalence and product quality standards evolve with scientific advancements. Discussions highlight the significant shift in the generic industry towards more complex products, which now represent a growing portion of submissions and require advanced scientific approaches. Key research areas and challenges explored include managing impurities like nitrosamines, characterizing complex active ingredients such as recombinant peptides and oligonucleotides, developing and assessing complex dosage forms and routes of delivery, and evaluating drug-device combination products. The session also addresses efforts to streamline the development of non-complex generics through global harmonization, alongside the increasing importance of quantitative medicine and artificial intelligence in improving the efficiency and consistency of scientific assessments and product development. The workshop serves as a vital platform for continued collaboration and public input to accelerate patient access to generic medicines.