Department of Health and Human Services May 19, 2009 – Federal Register Recent Federal Regulation Documents
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Gastrointestinal Drugs Advisory Committee; Cancellation
The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 20, 2009, is cancelled. This meeting was announced in the Federal Register of April 7, 2009 (74 FR 15739). The FDA's Center for Drug Evaluation and Research is continuing to review the application that was going to be discussed by the committee.
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 92 new drug applications (NDAs) and 49 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
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