ROCKVILLE, Md., Nov. 24 /PRNewswire/ -- The FDA issued the following:
As the first year anniversary of the enactment of the Food and Drug
Modernization Act of 1997 (FDAMA) approaches, FDA has met nearly all of the
deadlines for implementing the many varied provisions of the law. In many
cases the agency was able to complete these important initiatives well ahead
of schedule.
FDAMA is a wide-ranging piece of legislation affecting the work of each
the agency's key components. The law explicitly required FDA to complete 17
regulations, 11 guidance documents, 6 regulatory notices, 9 reports and at
least 18 other tasks. In addition, scores of other regulatory measures were
deemed necessary by the agency in order to effectively meet the law's
objectives.
To date the agency has issued 16 final rules, 9 proposed rules, 36
guidance documents, 11 regulatory notices and 1 report.
Initiatives that have been completed during FDAMA's implementation
include:
-- A final rule establishing parameters for distributing sound and
balanced information about "off-label uses" for marketed drugs,
biologics and medical devices. The new rule requires that the
dissemination of off-label information by a sponsor be tied to a
commitment to adequately research this use and submit it to the agency
for approval.
-- A guidance on FDA's fast track programs, which are designed to
facilitate the development and evaluation of new drugs and biologics
and designed to treat serious and life-threatening illnesses. The
guidance provides product sponsors and researchers with vital
information on how to maximize their product development efforts.
-- An agency plan for statutory compliance with FDAMA developed
through a series of "stakeholder" meetings conducted throughout the
United States. During these meetings, agency officials reached out to
the general public and to those segments of society most directly
affected by FDA work to solicit their views on how the agency can best
meet its public health mission. Representatives from consumer groups,
industry, health professional organizations, academia and other groups
participated in these forums, which provided the agency with valuable
insights, that will be used in its future policy and budgetary
considerations.
There are many other important aspects of the law which have been
implemented or are well on their way to being implemented. FDA is continuing
its efforts to attain all of the FDAMA objectives as quickly as possible.
For further information on FDA's FDAMA-related activities one can
visit FDA's FDAMA Web site at http://www.fda.gov/opacom/fdamact. This site provides
an updated, comprehensive listing of all of the agency's FDAMA implementation
activities as well as their current status.
SOURCE Food and Drug Administration
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