FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA: CBER Q&A Panel

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This webinar, presented September 4, 2024, offers essential insights into medical device development, guiding innovators through complex regulatory and market pathways. The Division of Industry and Consumer Education (DICE) serves as a primary resource at the Center for Devices and Radiological Health (CDRH), providing direct assistance with general medical device regulatory questions and creating valuable educational materials like Device Advice webpages, CDRH Learn videos, and Guidance Documents. DICE emphasizes the importance of early engagement with regulatory education and highlights the Q-Submission program for pre-submission consultations with FDA experts. Furthermore, the Medical Device Development Tools (MDDT) program is introduced as a voluntary pathway for qualifying tools that assess device safety, effectiveness, or performance, ultimately reducing regulatory burden and streamlining the review process. Lastly, the Early Payer Feedback Program addresses the critical step of ensuring patient access beyond FDA market authorization. This program facilitates early communication between device sponsors and payers, allowing for the alignment of clinical evidence requirements and potentially accelerating device availability to patients by integrating payer needs into pivotal clinical trial designs.

This session includes the Q&A Panel with:

Loni Warren Henderson
Public Affairs Specialist
Manufacturers Assistance and Technical Training Branch
Division of Manufacturers Assistance and Training
Office of Communication Outreach and Development
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)

Heather Erdman, MCPM, RAC, CQPA
Associate Director of Quality Assurance
Office of Review Management and Regulatory Review (ORMRR)
Office of Therapeutic Products (OTP)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)

Karin Knudson, PhD
CMC Reviewer
Office of Cellular Therapy and Human Tissue CMC (OCTHT)
Office of Therapeutic Products (OTP)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)

Devaveena Dey, PhD
Pharmacology-Toxicology Reviewer
Office of Pharmacology-Toxicology (OPT)
Office of Therapeutic Products (OTP)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)

Jessica Lee, MD, PhD
Branch Chief for the Oncology Branch 2 (OB2)
Division of Clinical Evaluation Oncology (DCEO)
Office of Clinical Evaluation (OCE)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA) (CDER)
US Food and Drug Administration (FDA)