FDA Regulations: Sustained Management Attention Needed to Improve Timely Issuance
HRD-92-35
Published: Feb 21, 1992. Publicly Released: Apr 01, 1992.
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Highlights
Pursuant to a congressional request, GAO reviewed Food and Drug Administration (FDA) efforts to improve its rulemaking process, focusing on: (1) the number of FDA regulations that are either under development and review or in pending status; (2) the general causes for delays in issuing regulations; and (3) FDA plans to issue regulations in a more timely manner.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | To improve internal management oversight of the FDA regulation process, the Commissioner, FDA, should develop a single automated regulation tracking system that: (1) monitors the progress being made on all regulations under development within the five FDA centers; (2) generates recurring reports to top agency officials and center directors; and (3) serves as the primary basis for identifying delays in issuing regulations and initiating appropriate actions, when necessary, to overcome internal delays in the development of individual regulations. |
Closed – Implemented
The FDA contractor completed prototype testing and an initial adjustment or familiarization process by agency personnel on July 30, 1993. FDA changed the date on which it plans to begin operation of an agencywide automated tracking system for all Federal Register documents from September 30, 1993, to March 31, 1994. This change was necessitated by additional unforeseen work associated with establishing the agencywide system. FDA continued to have problems, however, and further adjustments to the system were necessary. In the interim, FDA trained its staff on how to use the system. The system became operational on August 31, 1994.
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Food and drug lawInformation systemsInteragency relationsManagement information systemsRegulatory agenciesSafety regulationPrescription drugsFederal rulemakingFederal registerMedical devices