Fact Sheet: FDA Good Guidance Practices 

 FDA guidances are documents that explain the agency’s interpretation of, or policy on, a 

regulatory issue. The FDA prepares guidances primarily for industry, but also for other 

stakeholders and its own staff, and uses them to address such matters as the design, 

manufacturing, and testing of regulated products; scientific issues; content and evaluation of 

applications for product approvals; and inspection and enforcement policies. 

 Although guidances are not legally binding, they show stakeholders one way to reach 

their regulatory goal. However, stakeholders are free to use other approaches that satisfy the 

relevant law and regulations. Recently, FDA published a report on how to improve the 

processes that make these important documents available. 

Guidance Development 

 FDA issues more than 100 guidances each year. In fiscal year (FY) 2009, for example, 

FDA issued approximately 124 draft and final guidance documents; in FY 2010, the total was 

approximately 133, and in FY 2011, it was approximately 144. FDA develops two types of 

guidance documents - Level 1 and Level 2. In general: 

 Level 1 guidances set forth the agency’s initial interpretations of new significant 

regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy; 

and deal with complex scientific or highly controversial issues. 

 Level 2 guidances usually address existing practices or minor changes in FDA’s 

interpretation or policy. 

 Industry, consumers and other stakeholders play a significant role in the agency’s 

guidance development processes. FDA welcomes individuals’ and stakeholders’ suggestions of 

topics for guidances, and in certain instances solicits draft proposals. Draft proposals can help 

the agency better understand stakeholder positions, particularly if the subject involved deals 

with novel scientific issues. 

 The agency also invites the public to comment on its draft Level 1 guidances and 

reviews and considers the submitted comments in preparing the final documents. In some 

instances, FDA may hold public meetings or workshops on draft Level 1 guidance to solicit 

additional comments, or it may present draft Level 1 guidance to an advisory committee for 

review. 

 Although Level 2 guidances and Level 1 guidances “for immediate implementation” are 

implemented without prior public comment, all FDA guidances are posted on the agency’s Web, 

and anyone can submit comments on any guidances after they are implemented. FDA reviews 

those comments and revises the guidances, if necessary. 
A Blueprint for Improvement 

 As part of the Transparency Initiative, Dr. Margaret A. Hamburg, the Commissioner of 

Food and Drugs, called for a cross-Agency working group to prepare a report identifying FDA’s 

“best practices” for making the agency’s guidance development processes more transparent 

and efficient. 

 The working group, under the leadership of the Office of Policy in the Office of the 

Commissioner, prepared a report, entitled the “Food and Drug Administration Report on Good 

Guidance Practices: Improving Efficiency and Transparency” (GGP Report). This report may 

be found at 

http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM285124.pdf,

and it is open for comment by interested parties.