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Session 4: Regulatory Pathway by Center
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- Devices
- Pre-market application (PMA)
- 510(k) and HDEs
- Drugs
- 505(b)(1) original
- 505(b)(2) hybrid
- 505(j) ANDA
- Biologics
- 351(a) original
- 351(k) biosimilar
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