US drug regulation: Congress finds FDA wanting

Compassion vs Control: FDA Investigational-Drug Regulation

Victims of AIDS and other incurable diseases are denied access to potentially valuable experimental drugs by the U.S. Food and Drug Administration. Under the present law, no new drug or medical device can be sold until it has been approved as safe and effective" by the FDA. New-drug approval is an expensive process that routinely takes years to complete. Unapproved experimental products cannot ...

Policy Coherence in US Tobacco Control: Beyond FDA Regulation

As the Obama administration moves to enact meaningful and comprehensive health care reform in the United States, tobacco control must be elevated as a public health priority [1]. Though tobacco control efforts have been recognized as a top public health achievement of the 20th century [2], tobacco use continues to be the leading preventable cause of death in the US [3]. As Box 1 shows, the US b...

The cosmetic/drug dilemma: FDA regulation of alpha-hydroxy acids.

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...

Drug wanting: behavioral sensitization and relapse to drug-seeking behavior.

Repeated exposure to drugs of abuse enhances the motor-stimulant response to these drugs, a phenomenon termed behavioral sensitization. Animals that are extinguished from self-administration training readily relapse to drug, conditioned cue, or stress priming. The involvement of sensitization in reinstated drug-seeking behavior remains controversial. This review describes sensitization and rein...