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The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have long impeded the clinical translation of pharmacogenomics.

Personalized medicine uses genetic and other screening tests to predict a patient's response to specific drug and biologic therapies (together "drugs"), with the aim of choosing a treatment that will provide benefits while avoiding drug-related harms. There are two schools of thought on how tort liability may affect personalized medicine, i.e., whether fear of lawsuits will tend to accelerate progress or slow it down. Tort suits include product liability suits against manufacturers and negligence suits against physicians and other providers of health-related services.

Protecting the public from faulty targeting of medicines, while preserving the crucial distinction between product and practice regulation, may require innovative regulatory approaches and close, ongoing involvement by the medical profession. This article explores four problem areas: validation of clinical claims for tests used in targeting therapies; developing and implementing appropriate restrictions on off-label use; promoting consistent concepts of clinical utility for use in various regulatory, reimbursement, and judicial contexts; and communication of clear information to guide clinicians in appropriate use of targeted therapeutic products. The article suggests an approach for addressing these problems by sharing regulatory activities between the Food and Drug Administration and a newly-created clinical standards board formed within the medical and scientific communities.

Educators have a responsibility to help children deal with crises, such as death, by doing the following; Educators have a responsibility to help children deal with crises, such as death, by doing the following; (1) acknowledge the reality as soon as possible, (2) provide an environment where children feel comfortable discussing their feelings, (3) provide learning opportunities with curriculum so children may understand what has transpired. It is my hope that the means I used to incorporate the subject of death into the curriculum can be adapted by other educators. Additional resource material can be found in They Need to Know and Discussing Death.