FDA reform moves through Congress

FDA Reform: Déjà Vu Encore

The Food and Drug Administration (FDA) creates the climate for the development of new drugs and clinical research. A 30 year struggle to bring drugs to the market more rapidly culminated in the 1992 Prescription Drug User Fee Act (PDUFA). While drug review times have shortened, concerns about drug safety possibly associated with more rapid reviews have led FDA and Congress to tighten safety req...

TSCA Reform Under Way in Congress

Three decades ago, President Gerald Ford signed the federal Toxic Substances Control Act (TSCA 1976) to restrict or ban the use of toxic chemicals. The world has changed remarkably since the inception of TSCA. There are new chemicals and materials today, including those created using nano technology—only a dream in 1976. Our understanding of chemi cal hazards and the techniques used to evaluate...

FDA Reform and the European Medicines Evaluation Agency

Products Liability Reform in Congress: An Issue of Federalism

Congress is likely to approve generic drug user fees: action should spur faster FDA approvals.

$824 billion in the last decade. The cost savings benefit is obvious, and some even claim that generic products can be safer than their brand-name counterparts. Edith A. Rosato, RPh, Chief Executive Officer at the Academy of Managed Care Pharmacy, explains: “Generic drugs, by definition, are versions of brand-name drugs that have been available in the marketplace for many years. The longer a dr...