The U.S. Food and Drug Administration (FDA) recently released two reports outlining its strategies for improving communication with stakeholders and developing guidance documents. The report on communications lists seven ways the FDA communicates with stakeholders, while the report on guidance documents describes the process to create new or update guidance documents, standardized format, and review and release processes.
The FDA’s report on communication highlights the tools and methods it has traditionally used to engage with stakeholders, such as its website, webinars, meetings, and guidance documents. FDA’s website is its primary way to communicate about everything it does. With about 500,000 unique visitors every day, the FDA.gov website is the most popular regulatory affairs site in the world. The website contains information on every product regulated by the Agency, along with information on all activities conducted by the FDA. It contains information on public meetings, FDA’s processes, product approval information, registries, forms, educational material, laws and regulations related to FDA-regulated products, and almost any other information needed by the regulated industry and consumers.
The second way the FDA communicates is via town halls and webinars where its experts present on various topics of general interest, and allow the public to air its comments directly to the FDA. The FDA is also a prolific social media user. Its Youtube channel offers almost 3000 videos and together it has about 4 million followers across the social media platforms. FDA’s experts also blog and author podcasts that are primarily released on its website and promoted across the various social media platforms. FDA staff attends almost every professional conference and lead hundreds of meetings both internally and in collaboration with professional associations. FDA also routinely uses media channels to publicize it activities to the stakeholders. These press releases discuss news worthy FDA activities and other relevant communications. The FDA also communicates with the stakeholders via phone and emails. The phone numbers of all departments within FDA and the directory of key FDA personnel is available on FDA’s website allowing stakeholders to directly talk with the FDA staff for various issues. These interactions are in addition to the confidential interactions FDA staff does with sponsors of various applications to the Agency.
For the Guidance Documents, the FDA uses uniform formatting while allowing for flexibilities needed for diverse topics. The FDA has also received suggestions to make guidance documents easier to understand and revise, such as using Q&A formats, bullet points, flowcharts, and real-world examples. The agency plans to incorporate these tools to enhance readability. The FDA will also continue including references to relevant laws and regulations in its guidance documents and ensure these resources are readily accessible through its website.
Over the report on communications and Guidance Documents provide a summary of various practices that have primarily evolved over the last two decades.
