New Transparency Report Released by US FDA

Posted 30 December 2011 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released a report on Friday that details good guidance practices used by the agency when formulating guidance documents.

The report, the most recent output from the FDA's Transparency Initiative, notes that the agency issues over 100 draft or final guidance documents each year-a number that has been steadily increasing over the last three years.

In FY 2009, the agency issued 124 draft and final guidance documents.  That number increased to 133 in FY 2010 and 144 in FY2011. This represents a 7.26% increase from 2009 to 2010, and an 8.27% increase from 2010 to 2011.

The report breaks down in to five chapters, each explaining a different stage in the guidance creation process.

  • Chapter 1: Initiating guidance
  • Chapter 2: Prioritizing/work planning/tracking guidance
  • Chapter 3: Developing Guidance
  • Chapter 4: Reviewing and Clearing Guidance
  • Chapter 5: Issuing Guidance and Outreach

The report notes that the agency typically develops two types of guidance documents-Level 1 and Level 2 guidance documents.

Level 1 guidance documents are initial interpretations of "new significant regulatory requirements", and describe how the new guidance differs from existing regulations and deals with scientific difficulties and social controversies. These regulations are usually open to extensive comment periods and may be preceded by draft guidance documents.

Level 2 guidance documents are typically minor alterations to existing guidance documents, and explain the changes made to existing guidance documents. They may be immediately implemented, with commentary received from advisory committees taking the place of industry comments before implementation.

The report can be downloaded at the link below.

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