Lately, I've been thinking about how we can't make various decisions without going back to what data and the logic behind the drug's approval. I'd like to ask a question about how to search such documents.
I would like to know how to search for documents such as review reports that summarize "what data and the logic behind the approval of the drug."
If there is an advisory committee, like a U.S version of Japan's 'Pharmaceutical Affairs and Food Sanitation Council', I'd like to know how to search the committee meetings' minutes.
In Japan, the PMDA writes in their review-reports based on information from the drug and medical device review process regarding what data and logic behind the drug's approval. The 'Pharmaceutical Affairs Council'', a group of experts, review the review-reports (see Figure 1). I have asked separately about similar systems of Fig.1's in the U.S. and Europe. Contrarily, we would like to focus on how to get the review-reports or meeting-minutes in this thread.
Fig.1 Review Process for Drug or Medical Device Application in Japan(Quoted from here; it is in the public domain.)
In Japan, you can find such files by following way;
For almost all review-reports on drugs and medical devices approved in Japan are available on the web.
Some of the PMDA's review-reports have been translated into English.
English-translated versions are;
In addition, The meeting-minutes of the Council can be found in the following ways. But there are no English version.
- The minutes of the Council's deliberations against Avigan to the flu;
Minutes of February 3, 2014 (Written in Japanese)
- The minutes of the Council's deliberations against Stemilac;
Minutes of the September 2, 2015 (Written in Japanese)
Each of these minutes were a for the meetings held on the same day; therefore not separated from the proceedings on another product discussed on the same day.
In other words, my questions are;
- Are these kinds of documents available on the web in the U.S. and Europe?
- How to seek them?