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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.

My questions

  • 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.

enter image description here
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.

  • PMDA's Drug Review-Reports are available from here (Written in Japanese).
  • PMDA's Medical Device Review-Report are available from here (Written in Japanese).

Some of the PMDA's review-reports have been translated into English.

English-translated versions are;

  • English-translated PMDA's drug review reports are available from here.
  • English-translated PMDA's medical device review report are available from here.
  • English-translated PMDA's regenerative medicine review-report are available from here.

In addition, The meeting-minutes of the Council can be found in the following ways. But there are no English version.

  • Pharmaceutical Affairs and Food Sanitation Council (Division 1)'s meeting-minutes (Written in Japanese).
  • Pharmaceutical Affairs and Food Sanitation Council (Division 2)'s meeting-minutes (Written in Japanese).

For example,

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?
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I'll write down what I've just found out as an answer. However, this is not a complete answer.

(F1)How do I find the review reports on FDA approved drug?
The FDA's database on medical devices appears to be compiled here.

For drug, following you can find the review reports from here.

For example, if you search for the tamiflu, following two are hit.

Note that, the FDA seems to make a distinction between drugs and OTCs.

(F2)How do I find the review reports on FDA approved medical devices?
The FDA's database on medical devices appears to be compiled here.

(F3)How do I find the review reports on FDA approved regenerative medicine?
Here is the official list of regenerative medicine products that have been finally approved by the FDA.

Clicking on the name of each listed product will take you to a page where you can access the description and review information for each product. These pages has a link to a zip file containing all of the documents related to the review. For example, following Fig is a capture of the page for GINTUIT. On the following Fig, you can find the link for the Package Insert and "Approval History, Letters, Reviews, and Related Documents"
enter image description here

(F4)How do I find the meeting-minutes of FDA's committees?
Thanks to the @Chris Rogers 's answer to previous my Q&A, I found the following three articles on the FDA's website.

If you want to jump to conclusions, the minutes of all FDA committees can be obtained from the (F4-3)'s website above.

The (F4-1)'s web page has the following description, may indicating that the committee consults not all products.

So, how does the agency determine which products will undergo advisory committee review in the first place?

"Surprisingly," Sherman says, "many products do not make it to advisory committees." Those that do usually represent new technology or some element of controversy.

The web page of (F4-1) has the following description, indicating that the committee will consult not all products. The FDA has five centers, and the director of each center seems to have the discretion to decide whether or not to use the committees / which committees to use.

The decision to involve an advisory committee is usually at the discretion of the division director in one of the FDA's five product centers.

However, for the pharmaceutical products, it is common sense that one of the subcommittees under the committee on pharmaceutical products. For the medical devices, it is common sense that one of the subcommittees under the committee on pharmaceutical products.

The schedule of each committee can be found at the link of (F4-2).

As one example, let's look for the minutes of a committee meeting on a regenerative medicine, Mesoblast's Ryoncil for Pediatric GVHD. (This regenerative medicine appears to have been rejected by the FDA in October 2020.) Presumably, the ODAC minutes mentioned in this article can be accessed from here.


(E1)How do I find the review reports on EMA approved drug and regenerative medicine?

You can find review reports on EMA approved drug and regenerative medicine from here

Don't forget check On the "European public assessment reports (EPAR)"(See following Figure).

enter image description here

For example, that of tamiflu(drug) and alofisel(regenerative medicine) are available from the following links.

The database also seems to be able to search for "animal medicine" and "Withdrawn applications" depending on the settings.

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