Regulatory Differences Between Biopharmaceutics and Medical Devices

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?

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 510k 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.

Learning Objective:

At the end of this webinar, participants will understand regulatory similarities and differences between drugs, biologics, and devices.

Areas Covered in the Webinar:

• 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?

Gretchen Miller Bowker, serves as Chief Operating Officer for Pearl Pathways and has over 25 years experience in the development of drugs, biologics and devices. She is a recognized leader in regulatory, bioethics, and compliance. She has extensive experience in working in an academic research setting, large pharmaceutical companies, small biotech’s, and large device companies.