The Deregulatory State.
Public health can be achieved only through collective action. Individuals acting alone cannot protect themselves from work hazards, unsafe or ineffective vaccines and pharmaceuticals, impure food and water, a polluted environment, or epidemics. Only a well-regulated society can secure the essential conditions for health. Yet in this country, successive...

Prescription remedies.
A broad coalition of deregulators is gearing up to reform the FDA. How far will they go? "The Food and Drug Administration has made American drugs and medical devices the envy of the world," wrote Bill Clinton in his introduction to the March National Performance Review proposal to "reinvent"...

AGA Medical Receives Japanese Approval for AMPLATZER(R) Duct Occluder.
- Device Enables Minimally Invasive Closure of Common Structural Heart Defect - MINNEAPOLIS, Jan. 7 /PRNewswire/ -- AGA Medical Corporation ("AGA Medical") announced today that it received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its AMPLATZER(R) Duct Occluder (ADO). The ADO is...

Regulation of stem cell-based products.
As stem cell research moves toward offering more clinical applications, questions arise about how relevant products will be regulated. To date these questions have received relatively little attention compared to the legal and ethical issues associated with stem cell research, (1) but they will become increasingly important as technology...

Agency's approval plan flawed.
The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote "potentially dangerous uses" of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on...

Agency's approval plan flawed.
The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote "potentially dangerous uses" of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on...

Supreme Court upholds federal pre-emption of state device liability laws.
The U.S. Supreme Court Feb. 20 upheld federal preemption of state liability laws when it comes to lawsuits involving medical devices approved through PMAs. The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation, according...

What's in your medical future? Better health is just around the bend.
[ILLUSTRATION OMITTED] Do the high-tech diagnostic tests on TV shows such as House amaze you? Are you awestruck as doctors perform computer-assisted surgery on Grey's Anatomy? See how cutting-edge advances could change real-life medicine. 1 Computer chips will give instant access to your medical history....

Hydroxyapatite bone substitute. (Biomaterials).
A ceramic-based bone graft substitute for the augmentation of deficient maxillary and mandibular alveolar ridges is being introduced by Therics Inc, following US Food and Drug Administration (FDA) approval earlier this year. The synthetic hydroxyapatite is said to feature excellent shaping characteristics and the ability to be...

Sustaining public trust: falling short in the protection of human research participants.
An aura of complacency surrounds the protection of human research participants in the United States. From investigators to policy-makers, many involved in research are exhibiting bureaucratic resignation, allowing paperwork compliance and checkboxes to protect the rights and interests of participants. The routinizing of ethics gives some tangible assurance that...