Appropriations Report Outlines Separate FDA Post-Market Drug Safety Office
This article was originally published in The Tan Sheet
Executive Summary
Report language for a pending House appropriations bill for FDA outlines the need for an independent office within the agency to evaluate a drug's safety after it is marketed
You may also be interested in...
Congress Emphasizes Strings As FDA Asks For Greater Budget Purse
FDA Commissioner Margaret Hamburg's testimony before congressional appropriations subcommittees inspired a sense of déjà vu even though she was testifying on the agency's budget for the first time since assuming the post nearly 10 months ago
FDA Budget In Brief
Drug program proposal: FDA requests $1 billion in fiscal 2011 funding for its human drug program, a 13.6 percent increase from the prior-year appropriation, more than half of which would be covered by user fees. The figure presented Feb. 1 in the Obama administration's proposed budget includes $849.7 million for activities within the Center for Drug Evaluation and Research, and $150.5 million for Office of Regulatory Affairs field operations. The agency seeks $446.5 million for new drug review functions across both CDER and ORA. One area of ORA's domestic program - the OTC monograph project and health fraud project inspections - seeks $95 million for fiscal 2011, which would match the 2010 estimate. Of the $1 billion total for drug activities, $516 million is projected to come from user fees - largely those existing under the Prescription Drug User Fee Act. However, $34.4 million in new generic drug user fees and $2.5 million in field re-inspection user fees are proposed for fiscal 2011. The user fee component would represent 51.6 percent of total drug program funding in fiscal 2011, up from 47.2 percent of the 2010 appropriation
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC