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Who is on ODAC committee?

The Oncologic Drugs Advisory Committee, or ODAC, is the advisory committee responsible for making recommendations concerning new cancer drugs. Its membership includes experts in general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related fields.

Who is on the FDA Advisory Committee?

Advisory Committee members include: Scientific experts, including physician-researchers, statisticians, engineers, medical faculty, chemists, biologists, and other science-oriented professionals. Consumer representative. Industry representative. FDA Patient Representative.

How often does FDA go against advisory panel?

When advisory committees are convened, they usually offer recommendations in the form of a vote. Although the advice is nonbinding,3 the FDA tends to follow it. One analysis of votes from 2008 to 2015 found that the FDA acted against advisory committee advice only 22% of the time. Association of Advisory Committee Votes With US Food and National Institutes of Health (NIH) (.gov) articles PMC10329213 National Institutes of Health (NIH) (.gov) articles PMC10329213

How often does FDA follow advisory panel?

Findings. In this qualitative study of 409 advisory committee meetings, overall, 88% of FDA regulatory actions aligned with advisory committee votes, including votes on initial drug approvals, supplemental approvals, and safety actions.

Is the advice of advisory committees binding on the FDA?

Advisory committees provide independent advice and recommendations to the Food and Drug Administration (FDA) on scientific and technical matters related to the development and evaluation of products regulated by the Agency. Guidance for Industry: Advisory Committees - FDA fda.gov media download fda.gov media download

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