FDA Adverse Event Rule Halted At OMB By Administration Regulation Freeze
Executive Summary
An FDA proposed rule on reporting postmarketing adverse events is being held up at the Office of Management & Budget while the Bush Administration reviews new and pending regulations.
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FDA public calendar
Final rule eliminating FDA's prospective public calendar will be delayed 60 days until April 23. The postponement follows a regulation freeze by the Bush Administration (1"The Pink Sheet" Jan. 29, p. 10)