Food and Drug Administration
Briefing Information
Portions
of these documents may have been determined to be exempt from disclosure under
the Freedom of Information Act (the FOIA) (5 U.S.C. §552).
These redacted portions will appear as
white space on the screen or on the printed page.
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
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.
Bibliography