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THIRD-PARTY DRUG APPROVALS COULD RESURFACE ON REPUBLICAN AGENDA IN 104th CONGRESS; CHILDHOOD VACCINE GRANTS AS, PER ROWLAND/BILIRAKIS MAY ALSO REAPPEAR

Executive Summary

Safety and efficacy reviews of drugs, biologicals and medical device applications by groups outside the full-time FDA staff could be revisited in the upcoming Congress as the Republicans look for ways to shorten the FDA approval process. The idea has an important sponsor in the new Congress in presumptive House Speaker Gingrich (R-Ga.). In his de-bureaucratization push, Gingrich has solicited ideas for cutting back FDA hurdles to new product introductions.
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