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