Regulatory Focus™ > News Articles > FDA Withdraws 47 'Outdated' Guidance Documents

FDA Withdraws 47 'Outdated' Guidance Documents

Posted 05 May 2015 | By Alexander Gaffney, RAC 

FDA Withdraws 47 'Outdated' Guidance Documents

Forty-seven of the US Food and Drug Administration's (FDA) guidance documents were officially declared defunct today after regulators called them unfinished and outdated.

The guidance documents were eliminated in a 5 May 2015 Federal Register notice, Withdrawal of Guidance Published Before December 31, 2013.

The problem, FDA explains in the Register notice, is one of transparency and resources. Under FDA's Good Guidance Practices (GGPs), the agency is required to publish most guidance documents in draft form, which allows for the public to offer feedback. After feedback is collected and considered, the guidance document is then published as a "final" guidance document.

However, the feedback process can take months—even years—to complete, and during that time FDA's internal resources and priorities may change. That can leave draft guidance documents languishing in unfinished form for years, even as new scientific developments or broader shifts in policy render them irrelevant.

Those delays aren't uncommon, either. In a March 2015 letter to Congress, FDA revealed it takes, on average, between 425 days and 797 days to finalize a draft guidance.

How Long Does it Take FDA to Finalize a Draft Guidance Document?
Center
Minimum Days
Maximum Days
Median Days
CBER
261
1.975
743
CDER
194
5,405
710
CDRH
142
2,722
797
CFSAN
90
1,502
454
CVM
238
1,527
477
OSMP
280
2,124
687

When the guidance document development process takes too long, sometimes FDA is left with a document that is neither wanted nor useful to regulators or industry.

Such is the fate of 47 guidance documents FDA says it is immediately "withdrawing."

"Many of these draft guidances were not finalized most often because of higher priorities and resource issues," FDA wrote. "However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn."

While the effect of the withdrawals might be relatively small—guidance documents differ from regulations in that they are non-binding and are technically not supposed to be followed until they are made final—the documents cover a large number of products.

There are, for example, guidance documents on advisory committee meetings, bioengineered plants used in medical products, antibiotic resistance markers and gloves used in surgery.

A full list of the withdrawn guidance documents may be found below, or on FDA's website.


Categories: Regulatory News

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