In 2011, the FDA published the draft “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (here) that established the way that the FDA would prioritize, develop, and release guidances in draft or final, and identified two levels of guidances, a so-called Level 1 and Level 2. A Level 1 guidance document is one “that includes initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, unless FDA determines that prior public participation is not feasible or appropriate,” while a Level 2 guidance document is one that sets “forth existing practices or minor changes in policy.”
Since the first report cited above, the Agency has published a significantly greater number of guidances each year (from about 100 each year in the time span of 2005 to 2010 up to about 190 guidance documents in 2022-2023). In addition, the FDA learned a lot about urgent guidance document needs during the COVID-19 Public Health Emergency (PHE). The FDA recognized the simple fact that, in order to meet the pressing public health needs of the emerging pandemic, it had to modify its approach to the issuance of guidance documents in an expedited manner. Now that the PHE has been declared over, the Agency is asking for input on its learnings from that experience as well as the general procedure for guidance development and issuance as outlined in the newly issued December 2023 draft report titled “Food and Drug Administration: Draft Report and Plan on Best Practices for Guidance” (here) to assist in making the guidance issuance process more efficient, transparent, and timely.
The new report provides a background on the origin of the current system and policy for guidance development and issuance, discusses the impact and learnings from the COVID-19 PHE on the process, and outlines the Agency’s thinking on best practices for the initiation, prioritization, development, review, clearance, and issuance of guidance documents. “FDA’s ‘Draft Report and Plan on Best Practices for Guidance’ identifies our current best practices for the efficient prioritization, development, issuance, and use of guidance documents. As a part of this draft report and plan, FDA is also considering opportunities to streamline processes for regulatory submissions through the revision and issuance of guidance documents and to implement innovative guidance development processes and practices. Pursuant to Section 2505(c) of the Consolidated Appropriations Act, in this Federal Register notice announcing the availability of this document, FDA is seeking public comment on this ‘Draft Report and Plan on Best Practices for Guidance.’” The FDA is seeking comments “from a broad range of commenters, including regulated industry; researchers; academic organizations; pharmaceutical, biotechnology, and medical device developers; clinical research organizations; clinical laboratories; healthcare providers; food manufacturers; and consumer and patient groups.” Today, on the Federal Register prepublication page, the FDA announced the issuance of the new report and identified the areas of particular interest that the Agency would like stakeholder comments to address. The FR notice can be found here.
This is your chance to influence the process or suggest improvements. Make it a New Year’s resolution to do so!
