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The U.S. FDA appears to have five shortcut regulatory approval ways, as follows;

(1) Accelerated Approval
(2) Priority Review
(3) Fast Track
(4) Breakthrough Therapy
(5) RMAT:Regenerative Medicine Advanced Therapy

Many companies proudly state in their press releases that their products in development have been designated as one of these.

However, as far as I could find on the FDA's website, I couldn't find out whether those products were indeed designated. Furthermore, I'm not sure of the subsequent review and development of the products.

However, it would be too broad to ask about all five shortcut ways, so we'll focus on regenerative medicine here.

My Questions

  • Where can I get an up-to-date list of products that have been designated as RMATs or other products that have been designated but not yet approved, or that have once been applied to these shortcut ways?
  • Where can I find a list of the latest status of products under review in Shortcut Way?
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    Maybe this is not published online?
    – Thomas
    Aug 5 '20 at 0:07
  • @Thomas Yeah, thank you for your answer. I tried to look for it, but I couldn't find it, at least not on the FDA's website. Though the "number of cases on each shortcut route in each year" was on the FDA's website. Aug 6 '20 at 0:35
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Since no one has responded, I offer the following information as far as I have been able to find out myself.

There does not appear to be an official list of candidate drugs designated for RMAT at the moment. This means that until the drug is finally approved, we have to trust the news or the applicant's self-reporting.

I've made a concerted effort to find that list on the FDA's website, but I cannot find any list of RMATs. Only the number of RMATs by status appears to be officially available to the public.

One unofficial list says;

Here is a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT.
<omit>
Note that the FDA has recently updated it’s RMAT totals to indicate that it has approved 52 RMATs as of mid-2020 so about 8 are not in the public domain.

They, also seem to have made the list by checking the press release by the applicant against the total number released by the FDA.

Note that being designated/approved as an RMAT and being approved as a regenerative medicine are different things. The former merely gives them the right to simplify the review process. The latter seems to mean that the product has received permission to be sold in the US. A list of products approved for use in regenerative medicine can be found here.

So how many candidate drugs have been approved as regenerative medicine products via the RMAT way at this point?
The following description was found in this article.

Although the Agency has granted 52 RMAT awards as noted in the table above, as of 30 June 2020, none of the products had received approval yet.

However, I did not know how many of these were in clinical trials or under review and how many were jugged as Refusal to File (RTF).

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