A look at what remains on FDA’s 2022 guidance agendas

With just 81 days to go in the calendar year, four of the FDA’s major review centers – CDER, CBER, CDRH and CFSAN – have between them 102 guidance documents that they planned to publish in 2022. In this analysis, AgencyIQ explains the ins and outs of FDA’s guidance agendas, including the documents we might see by year’s end – or on next year’s agendas.

With less than 3 months left in the 2022 calendar year – just 81 days as this article is published – there are dozens of guidance documents remaining on the FDA’s various “guidance agendas,” according to a review by AgencyIQ.

First, let’s explain what a guidance agenda is.

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.45, the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” This list is known as the FDA’s “guidance agenda,” and in practice details the documents that FDA plans to release to the public, and not simply develop.

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center. These documents, though similar, do differ in several important respects. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), for example, publish agendas applicable to its calendar year. FDA’s Center for Devices and Radiological Health, meanwhile, publishes in accordance with the government’s fiscal year. CDER only releases a list of topics for which it is working to develop draft guidance, while CBER and CDRH specify the status of development (draft, revised draft or final).

There are other key differences as well. CBER and CDRH tend to publish relatively modest (but more attainable) development agendas, whereas CDER’s agenda is extensive but is rarely even a third complete by year’s end (although CDER also publishes more guidance than all other centers combined). Finally, while the FDA is required to publish its guidance agendas, these documents are often updated at least once during the course of the year to add new documents or to reflect that some documents have been published.

High-level findings

Now let’s look at what the FDA had planned for 2022 (or in CDRH’s case, for FY2022, which ended October 1).

Between the FDA’s three major product review centers – CBER, CDER and CDRH – the agency planned to release 158 guidance documents in 2022. FDA’s Center for Food Safety and Applied Nutrition (CFSAN), which regulates food products, also said it intended to release two dietary supplement-related documents, for a total of 160 guidance documents.

Status of guidance documents included in guidance agendas, by FDA review center

*Only reflects CFSAN’s two dietary supplement-related guidance documents. There are 26 total documents on its CY2022 guidance agenda.

As of October 12, 2022 the FDA four centers (CDER, CBER, CDRH and CFSAN) have released 58 guidance documents that were planned for release as part of their guidance agendas. However, there are an additional 102 guidance documents that were planned for release but that have not yet been published in either draft or final form. This equates to 36% of all documents planned for release in 2022.

What remains unpublished, and what’s next

So, what hasn’t yet made the “published” list, and what might we see in the remaining weeks of the calendar year?

AgencyIQ has gone through FDA’s list of published guidance documents, as well as our own analyses, to determine which guidance documents haven’t yet seen the light of day. Read on to see which documents remain in development as of October 12, 2022.

As a quick aside, this list is likely to change within the next few weeks. Because CDRH publishes according to a fiscal year basis, it has been in the habit of releasing its guidance agenda shortly after the start of the fiscal year, which began October 1, 2022. In FY2022 (October 1, 2021 through September 30, 2022), for example, it updated its guidance agenda on October 26, 2021. We’ll be sure to make note of that new agenda for our subscribers once it’s published.

But that being said, do not expect FDA to publish 102 guidance documents between now and December 31. A guidance document that is not released in a given year is most often recycled into next year’s guidance agenda, unless the agency has truly ceased development due to previously unforeseen circumstances or changes.

What can we expect the FDA to do in the remainder of CY2022? Let’s do some back-of-the-envelope math to develop an estimate. In FY2022, FDA released an average of 13.75 guidance documents per month related to medical product regulation and dietary supplements (i.e., excluding food, veterinary and tobacco products). With 247 work days in FY2022 (excluding weekends and holidays), the FDA published one guidance every 1.5 work days, on average.

With just 52 work days left in CY2022, we can therefore expect the FDA to publish approximately 34 additional guidance documents before January 1, 2023. Of course, there are other factors to consider, such as typical slowdowns around the holidays. But if we had to guess, we’re likely to see somewhere between 25-30 guidance documents before the end of the year.

Unpublished guidance, by FDA center:

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Drug Evaluation and Research

Center for Food Safety and Applied Nutrition

To contact the author of this analysis, please email Alec Gaffney ([email protected])