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The Prescription Drug User Fee Act (PDUFA) expires in September, therefore FDA may need to warn drug reviewers that their jobs may be eliminated if Congress does not honor the reauthorization deadline.

Nausea and vomiting (emesis) are among the most distressing side effects of chemotherapy and are associated with significant clinical consequences. Four distinct types of chemotherapy-induced nausea and vomiting (CINV) have been described: acute, delayed, anticipatory, and breakthrough. Clinical practice guidelines provide specific recommendations for controlling the different types of CINV depending on the emetogenic potential of the chemotherapy regimen being used. Three classes of antiemetics are considered potent and well-tolerated options: 5-HT3 serotonin-receptor antagonists, corticosteroids, and neurokinin-1-receptor antagonists. Phenothiazines, butyrophenones, cannabinoids, metoclopramide, and benzodiazepines are also sometimes used to prevent CINV caused by minimally emetogenic chemotherapy or to treat breakthrough CINV. This article reviews the currently available antiemetic agents and clinical practice guidelines for the management of CINV.

Schizophrenia is a chronic psychiatric disorder that affects an estimated 1% of the population. This disorder may be treated with typical (first-generation) or atypical (second-generation) agents; a recognized concern regarding these agents is that long-term use has been associated with increased risks of serious side effects, either neurologic or metabolic in nature. Bifeprunox is a partial dopamine-receptor agonist under investigation for the treatment of patients with schizophrenia.If approved, bifeprunox may serve as an additional option for the acute and maintenance treatment of schizophrenia.

The latest FDA action (through June 2007) related to sipuleucel-T (Provenge), tramadol (CIP-Tramadol ER), isotretinoin (CIP-Isotretinoin), bazedoxifene (Viviant), irbesartan plus hydrochlorothiazide (Avalide), prednisolone 1.0% plus tobramycin 0.3% ophthalmic suspension (T-Pred), pixantrone, SPRC-AB01

A number of cost-evaluation studies have emerged showing consumer-directed health plan (CDHP) members use less care. Meanwhile, others suggest that members are less satisfied with these plans and that they tend to choose unwise ways of saving money, such as skipping preventive care.

The mother of a child suffering from asthma calls Medical Mutual of Ohio's Nurse Line desperately needing advice. The nurse listens to the mother's concern and is poised to tell her everything she needs to know, but instead, the mother is told that she is not covered for this particular service.

Physician financial incentives can be a powerful tool to motivate physicians to improve hospital-related practice patterns which can save health plans millions of dollars in reduced hospital costs.