This article has the following descriptions;
"Perhaps what is most surprising is that in mid-August, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 1 to recommend the drug for that indication. Although the agency isn't required to follow an advisory committee's recommendation, it usually does."
According to that article, at least two groups are involved in the final stage of the FDA's approval process: the 'Oncologic Drugs Advisory Committee (ODAC)' and the 'agency'.
- In the final stage of FDA's approval process, what does the 'AGENCY'? What is the role of them? Is this the group writing the review report?
- What kind of Committees or Groups involve the review at the final stage of approval?
- How is the relationship between the groups or committees or ... involved? (In Japan's case, it appears to be as shown in Figure 1 below.)
Fig.1 Review Process for Drug or Medical Device Application in Japan(Quoted from here; it is in the public domain.)
Other article has following description
While the advisory committees’ recommendations are not binding, the FDA typically follows those endorsements when it comes to final approval of a new drug. A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.
In a previous Q&A, I asked about the entire process from R&D to approval. In this board, I'd like to focus on the final stages (around NDA / BLA) to get approval from the FDA.
- The PMDA reviews all drugs or medical devices to be approved in Japan.
- After PMDA's review, the reasons, logic, rationale, and so on behind the decision to approve a drug or medicine are reported on the PMDA's review reports.
- PMDA's review reports are further reviewed by the 'Pharmaceutical Affairs and Food Sanitation Council'. This Council may be a regularly scheduled gathering of experts.