Food and Drug Administration

Joint Session of the

Nonprescription Drugs Advisory Committee

and the

Dermatiologic and Ophthalmic Drugs Advisory Committee

March 24, 2005

Briefing Information


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Food and Drug Administration


This briefing document has been prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee.
The FDA background package often includes initial and/or preliminary conclusions and recommendations written by individual FDA reviewers
These conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the FDA. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been completed.



FDA Executive Summary

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Tab 2 Recommendations Regarding the Safety and Effectiveness of Hydrocortisone,

Advance Notice of Proposed Rulemaking (44 FR 69768 at 69813 - 69824) 1979.


Tab 3 FDA Concurrence with the Recommendation of the Topical Analgesics Panel,

Tentative Final Monograph (48 FR 5852 at 5865 - 5869), 1983.


Tab 4 FDA Recognition that Hydrocortisone is Safe and Effective as an OTC Antipruritic

Active Ingredient at Concentrations up to 1.0 Percent, Amendment of Tentative Final Monograph

55 FR 6932), 1990.



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