Drugs

Vivek Subbiah: The FDA just finalized the draft guidance for ‘RARE DISEASE DRUG DEVELOPMENT’

Photo taken from Vivek Subbiah/LinkedIn

Dec 27, 2023, 14:02

Vivek Subbiah: The FDA just finalized the draft guidance for ‘RARE DISEASE DRUG DEVELOPMENT’

Vivek Subbiah recently shared on LinkedIn:

“Wow! The FDA just finalized the draft guidance for ‘RARE DISEASE DRUG DEVELOPMENT’.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘Rare Diseases: Considerations for the Development of Drugs and Biological Products’. This guidance is intended to assist sponsors of drugs and biological products for treatment of rare diseases in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development.

This guidance finalizes the draft guidance entitled ‘Rare Diseases: Common Issues in Drug Development’ issued on February 1, 2019.”

Additional details.
Source: Vivek Subbiah/LinkedIn

Vivek Subbiah is the Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute (USA). He is the former Executive Director of Oncology Research at the MD Anderson Cancer Network and a former Associate Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

Dr. Vivek Subbiah has served as the principal investigator in over 100 phase I/II trials and co-investigator in over 200 clinical trials and is known for his leadership in several first-in-human and practice-changing studies that directly led to approvals from the FDA, European Medicines Agency, and other agencies across the world. He is an expert in tumor agnostic precision oncology and leads the BRAF and RET tissue agnostic studies to FDA approval.