Medical Letter on the CDC and FDA

Head and Neck Cancer - Nitric oxide accelerates regression in head and neck cancer

Heart Disease Therapy - Sarpogrelate possesses cardiovascular and renal clinical potential

Hematology - Reactions with haptoglobin-hemoglobin complex modulate NO reaction products

Hemorrhagic Fever - Crimean-Congo hemorrhagic fever virus outbreak in Turkey confirmed by testing

Human Papillomavirus Vaccine - Human papillomavirus in cervical cancers in Mozambique genotyped

Imaging - Swedish regulatory authorities to approve novel imaging drug Hexvix

Immunology - Company initiates phase III clinical trial for FavId

Immunotherapy - FDA accepts sBLA for expanded use of BEXXAR; decision expected by January 2005

Influenza - Association launches flu-shot locator

Influenza - Importance of influenza vaccination as season opens stressed by U.S. officials

Influenza - Influenza A virus outbreak in Israel infected primarily neonates and infants

Influenza - Newest recommendations highlight the urgency for childhood influenza vaccination

Influenza - Vaccines are first line of defense for flu prevention, antivirals can play role

Information Technology - Companies form alliance to automate HIPAA transaction processing

Information Technology - Consulting firm chosen to perform assessment of hospital information systems

Injury Prevention - Big cities and small towns at similar risk of gun death

Kidney Disease - Renagel REACH program expands access for Medicare beneficiaries

Lab Devices - FDA approves manufacture of Pyrotell Single Test Vials at new facility

Laparotomy - Data published from Entereg (alvimopan) phase III clinical trial

Legal Issues - Employee fired in 2002 sues Los Alamos lab

Legal Issues - U.S. Government to collect $11.3M for expenses from silicone breast implants

Leishmaniasis Therapy - Macrophage-specific drug delivery for leishmaniasis developed

Leishmaniasis Vaccine - Current status of leishmaniasis vaccine development reviewed

Leishmaniasis Vaccine - Progress in vaccine research for visceral leishmaniasis reviewed

Lymphoma - SGN-30 phase 2 clinical trial for cutaneous lymphoma initiated

Macular Degeneration - Pfizer, Eyetech and partner provide regulatory update on Macugen

Malaria - Role of Plasmodium falciparum genes in malaria in pregnancy reviewed

Medical Devices - Hospital uses carotid stent device to open blocked arteries in the neck

Medical Technology - Life sciences company receives drug approval for ICG-PULSION in E.U. countries

Medication Access - Accord on better access to essential medicines for poor reached at WHO meeting

Melanoma - U.S. FDA authorizes start of phase 2 clinical trial on melanoma vaccine

Meningococcal Disease - FDA panel recommends licensure of Menactra vaccine

Monoclonal Antibodies - Monoclonal antibodies and therapeutics reviewed

Mycobacteria - Genomic analysis distinguishes Mycobacterium africanum

Myelodysplastic Syndromes - EMEA accepts marketing authorization application for Vidaza for review

Neuroscience - Magnocellular neuron gene expression determined in supraoptic nucleus

Non-Hodgkin Lymphoma - Marqibo to be reviewed by FDA Oncologic Drugs Advisory Committee

Nosocomial Infections - FDA grants Aurexis fast track designation

Nutrition - Buyer beware: Product labels don't always measure up

Obstetrics - Monitoring technology for safer births studied at Kaiser Permanente

Obstetrics - Partnership aims to stop the invisible epidemic of maternal deaths

Obstetrics - Photo report follows six women during pregnancy and childbirth

Occupational Health - Respirable coal dust modifies cytochrome expression in rat alveolar cells

Ophthalmologic Surgery - U.S. FDA approves device for separating corneal tissue during surgery

Oral Cancer - Saliva plays role in development of oral cancer

Osteomyelitis - FDA gives nod to additional phase II trial of INFECTON

Otitis Media - Inaugural Pulsys phase III trial to begin

Pain - FDA approves ANDA for Oxycodone Hydrochloride Controlled Release Tablets, 80mg

Pain Medicine - Phase III trial begins for analgesic Bicifadine

Patents - Company receives U. S. patent for de-identified patient encryption process

Patents - Court overturns cord blood patent infringement verdict, denies injunction

Pediatric Obesity - New DVDs to help combat childhood obesity

Percutaneous Coronary Intervention - Company gets E.C. approval to market anticoagulant for PCI patients in Europe

Prescription Drugs - Allergan psoriasis treatment tazarotene denied approval by FDA

Product Distribution - Medical devices company picks distributor for rapid skin anesthesia product

Product Licensing - U.S. FDA grants tentative approval for generic antihistamine HCL tablets

Prostate Cancer - Elderly African American men less likely to undergo prostate cancer screening

Public Health - Professor: Local health campaigns not reaching adults with bad habits

Public Health - Rural veterans face lower quality of life than urban counterparts

Public Health - Socioeconomic status is a significant predictor in understanding an outbreak

Pulmonary Hypertension - Endothelin ET_A receptor antagonist reverses pulmonary hypertension

Pulmonary Tuberculosis - Late diagnosis of pulmonary tuberculosis led to community outbreak

Pulse Oximetry - Flexistat Oximetry Sensors receive U.S. FDA approval

Quality Assurance - Health plan named to top 10 by National Committee for Quality Assurance

Regulatory Issues - Amendment to PMA-S submitted to FDA in response to not-approvable letter

Regulatory Process - Company reiterates Enhanze SC NDA timeline

Respiratory Syncytial Virus - V beta 14+ T cells mediate disease induced by RSV G glycoprotein

SARS Epidemiology - SARS rates vary among three categories of hospital workers in Hong Kong

Sexual Desire Disorder - FDA grants priority review to testosterone transdermal system for HSDD

Sexual Dysfunction - Positive results reported on phase II study of LibiGel

Smallpox - FDA clinical hold for ACAM2000 removed, BLA submission planned

Stem Cell Research - NIH grants new money for more research into Alzheimer, spinal cord injuries

Stress - Vietnam veterans had higher death rates after discharge than other veterans

Stroke - New Jersey hospital to offer newly approved stent device to prevent stroke

Trichomoniasis - Xenostrip-Tv is rapid and accurate test for Trichomonas vaginalis

Tuberculosis - CDC funding to be used for development of TB vaccine trial sites in India

Tuberculosis Diagnosis - ESAT-6 and CFP-10 protein peptides used to detect M. tuberculosis

Tuberculosis Transmission -  Mycobacterium tuberculosis transmitted via lung transplantation

Tuberculosis Vaccine - DNA vaccine activates CD8+ cells and reduces lung injury in TB

Type 2 Diabetes - Millions of Asian Americans and Pacific Islanders at increased risk

Virology Vaccine - Progress on vaccine strategies against viral infections reported

Water-Borne Illness - New arsenic drinking water standard may still be toxic

West Nile Virus - Recovery at 1 year is poor in elderly persons with West Nile virus infection