Biopharmaceutics vs. Medical Devices: Similarities and Differences in the FDA Regulatory Paths
Why are FDA regulatory submission requirements so different for biopharmaceuticals and devices? This webinar will review FDA regulatory requirements for approval of drugs and biologics and the clearance of medical devices. You will gain an understanding of the Centers for Drugs (CDER), Devices (CDRH), and Biologics (CBER), their requirements for clinical research (IND vs. IDE), as well as the path for approval or clearance to sell product in the US.
You will learn about the path for 501k clearance or PMA (pre market approval) for devices, and NDA (new drug applications) and BLA (biologics license applications) for biopharma products. Combination product regulations will also be reviewed.
Why should you attend: Do you currently have responsibility in the regulatory group for drugs but want to learn more about devices or vice versa? Are you confused by all the FDA Centers and want to know the applicable FDA division for your technology? Are you launching a drug-device combination product and need to map out a parallel regulatory path? Would you like to do a clinical research study utilizing a non-approved drug or biologic? Do you want to know if a device meets the category for IDE exemption?
If yes, you should consider attending this one-hour webinar which will educate you on the similarities and differences in the regulatory paths and requirements for these products.
This session will review FDA regulatory requirements, the applicable FDA “Centers,” the IDE and IND process, as well as 510k, PMA, NDA and BLA submission processes
Areas Covered in the Session:
Who Will Benefit:
- Review of FDA regulations for biopharma vs. devices
- FDA Centers: CDER, CBER, CDRH
- What if the product is a combination product…which do I lead with?
- What is the difference between the requirements for an IND vs. IDE?
- What are the requirements for a 510k (class I and II) and PMA submissions?
- What is needed for NDA and BLA submissions?
- Companies who sell, distribute or manufacturer drugs, devices, biologics, or combination products
- CRO Personnel who are involved in regulatory submissions
- Contract Manufacturers who provide regulatory submission data for their clients
- Regulatory Professionals