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Ishwaria Subbiah: Important FDA Update on Accelerated Drug Approval Process

Ishwaria Subbiah/LinkedIn

Jan 8, 2025, 15:29

Ishwaria Subbiah: Important FDA Update on Accelerated Drug Approval Process

Ishwaria Subbiah, Executive Director for Cancer Care Equity and Professional Wellness at Sarah Cannon Research Institute (SCRI), shared a post on LinkedIn:

“Important FDA Update on Accelerated Drug Approval Process and Opportunity to Submit Comments.

Submit your comments on the FDA’s new draft guidance regarding confirmatory trials for drugs under accelerated approval. The changes reflect expanded authority given by recent Congressional amendments to the FD&C Act through the 2023 Consolidated Appropriations Act.

Key changes include:

FDA’s new authority to require studies to be ‘underway’ before or shortly after drug approval
A clearer definition of what constitutes an ‘underway’ trial
Updated policies for implementing these requirements

This guidance particularly impacts rare diseases and hashtag#cancer treatments where early access must be balanced with confirming clinical benefits. Whether you’re in industry, clinical research, patient advocacy, or other stakeholder, your input is valuable.

Don’t miss this opportunity to shape how the FDA implements these important changes.”

Ishwaria Subbiah: Important FDA Update on Accelerated Drug Approval Process

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Ishwaria Subbiah is the Executive Director for Cancer Care Equity and Professional Wellness at Sarah Cannon Research Institute (SCRI). She is also the medical director of supportive care oncology, health equity, and professional well-being at The US Oncology Network.

Dr. Subbiah focuses on reducing cancer outcomes disparities and diversifying clinical trial participation within SCRI’s combined research network of more than 1,300 physicians at over 250 locations in 24 states across the US. Dr. Subbiah is a globally recognized expert in geriatric oncology, symptom management, palliative care, and healthcare professional well-being.

She previously was an associate professor in the Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. She is the Chair of the ASCO Women in Oncology working group and the ASCO State of Cancer Care in America initiative.