You’re invited to attend a NEW workshop on complex generic drug-device combination products!
Join scientists and policy experts from the FDA, and other leaders in the field, as we discuss current scientific and regulatory perspectives at the FDA and DIA co-sponsored Complex Generic Drug-Device Combination Products Workshop, October 9-10, 2018 in Silver Spring, Md.
Why Attend?
- Get the latest updates on innovative scientific methods and ongoing research efforts to address the challenges associated with the development of generic drug-device combination products.
- Bring your questions and have them answered by leaders in industry, academia, and at the FDA.
- Learn about the scientific considerations and associated challenges in demonstrating pharmaceutical equivalence for generic drug-device combination products.
- Join in scientific discussion on quality and manufacturing issues related to generic drug-device combination products.
- Connect with key staff and leadership from the FDA Generic Drugs Program, including Keynote Speaker Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
Hot Topics
- Complex generic drug-device combination products and product development
- Best ways to overcome certain challenges and hurdles to getting your generic drug-device combination products approved and marketed
- Quality considerations for generic drug-device combination products
- Regulatory considerations for drug-device combination products submitted in ANDAs
- How to interpret product-specific guidances
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