Department of Health and Human Services June 28, 2005 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.'' The draft guidance is intended to assist sponsors in developing clinical trials for drug products that treat or prevent gingivitis. It addresses specific protocol design elements as well as general concerns about drugs for this indication.
Draft “Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments;” Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on August 3, 2001.
Supplemental Financial Disclosure Requirements for Employees of the Department of Health and Human Services
This interim final rule extends the due date for NIH employees to file a report of prohibited financial interests held on or acquired after February 3, 2005. The reports are now due no earlier than October 3, 2005.
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