FDA 101 gives information about the agency to the public

Description: FDA 101 seeks to provide transparency about the agency and its activities to the public

FDA 101


FDA 101 is a part of FDA, Food and Drug Administration’s transparency initiative. It was initiated to explain to the public what the agency does, in a user-friendly manner. At present public seeking information from the agency can request for the information under the Freedom of Information Act (FOIA) by submitting the request form in the process suggested by the FDA.

Transparency Task Force

As a part of this initiative a transparency task force was formed with the representatives from each of the offices of the FDA. The transparency task force collects the information that the public would like to know from the FDA, such as the regulations, how they operate, decision-making, in what circumstances enforcement actions are required, or any questions about the drug recall efforts and such other questions.

After collecting the information from the public, the transparency task force aims at preparing a FDA 101 curriculum for educating the public about the FDA and related activities.

The transparency task force hascreated a blog site where in the task force discusses the various ways information about the FDA can be shared with the public. This blog site is expected to run for a scheduled period of time, after which based on the suggestions and inputs from the public the FDA 101 will be designed. (http://fdatransparencyblog.fda.gov/?s=FDA+101)

Action points for the Transparency Task Force

  • Seek public input on transparency related issues;
  • Recommend different ways in which the agency operations, activities, processes, and decision making, can be explained ;
  • Identify information FDA should share about specific agency activities, operations,decision making,  processes, and recalls, enforcement actions, and product approvals;
  • Identify internal or external problems and barriers to providing useful and understandable information about FDA activities considering health, literacy and needs of special populations;
  • Identify tools and new technologies information sharing;
  • Recommend changes to FDA’s current operations  in order  to provide information to the public in a timely and effective manner;
  • Recommend legislative or regulatory changes;
  • Submit a written report to the Commissioner on the task force’s findings and recommendations.

The transparency task force strives to ensure that the implementation of the Task Force’s recommendations shall make FDA’s actions, decisions, and underlying processes more transparent to the public, at the same time, still meeting the agency’s goal of appropriately protecting confidential information. 


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Author: GlobalCompliancePanel-Training

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

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