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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . June 27th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Angiology - Study of decellularized carotid artery vascular grafts released

Measles Outbreak - Largest U.S. outbreak of measles in 1999 characterized

Rubella - Rubella virus P90 associates with cytokinesis regulatory protein

Smallpox Vaccine - Mouse neurotoxicity test for vaccinia-based smallpox vaccines developed

Acute Coronary Syndrome - FDA clears new intended uses for Troponin T test

Antibiotics - Antibiotic activity of field-collected Streptomycetes characterized

Antibiotics - FDA approves amoxicillin and clavulanate potassium for oral suspension

Asthma - FDA approves ANDA for Terbutaline Sulfate Injection

Avian Influenza - NIAID announces contracts to develop vaccine against H5N1 strain of bird flu

Benign Prostatic Hyperplasia - FDA warning letter clarified by biotech firm

Bladder Prolapse - FDA clears minimally invasive treatment for bladder condition

Bleeding - Application submitted to FDA to market autologous thrombin processing device

Breast Cancer - FDA grants approval for Gemzar in combination with Taxol

Breast Cancer - Mammography continues to be a highly effective screening tool

Breast Cancer - Possible new mechanism suggested for estrogen's promotion of disease

Business Update - Drug developer to realign product development strategy

Cancer Diagnostics - S100C staining may aid diagnosis of thyroid lesions

Cardiology - FDA issues marketing clearance for cardiac flat-panel detector

Cardiology - Potential treatment for aortic aneurysm repair surgery given FDA fast track status

Childhood Immunization - More work needed on national immunization registry

Chirality - Method to determine chirality determination of amino acids developed

Diagnostics - FDA requests and approves new name for infection imaging product

Diet and Nutrition - S-adeno-syl-L-methionine in dietary supplements characterized

Drug Access - New campaign against reimportation launched

Drug Advertising - FDA warning letter issued on promotional materials for Advate

Drug Approval - New survey highlights FDA's successes and failures

Drug Delivery - Patent awarded for new measurement system for pharmaceutical sprays

Environmental Health - Insulin-like growth factor 1 increased in people exposed to pollutants

Environmental Toxins - CDC offers $1.5 million for thyroid study of downwinders

Fitness - Study: Driving longer means larger waists

Food-Based Disease - United Nation's agencies call food safety a risk in Asia and the Pacific

Gastroenteritis - Licensing agreement will further research into norovirus treatments

Gastroenteritis - New license agreement for norovirus detection technology

Gastrointestinal Disease - FDA approves gastrointestinal selective antibiotic

HIV Prevention - CDC awards $49 million to support HIV efforts in communities across the U.S.

Health Risk - Soap, insect nets over beds shown to be simple disease-fighting tools

Healthcare Funding - Mexican tobacco companies to contribute $350 million to health system

Hepatitis - Hepatitis A virus cDNA-transfected Ltk-cells might reveal viral pathogenesis

Hepatitis A - Rates down dramatically among American Indians/Alaska Natives

Hepatitis A Vaccine - Benefits of hepatitis A vaccination for drug users investigated

Hereditary Angioedema - DX-88 placed on clinical hold pending review

Immunology - New phase I cancer trial planned

Infectious Disease - Modes of hantavirus transmission inferred from mitochondrial DNA analyses

Kidney Failure - Zemplar (Paricalcitol Injection) receives FDA approval for pediatric use

Lymphoma - FDA issues special protocol assessment for phase III trial of FavId

Malaria - Insect nets shown to be a simple disease-fighting tool in developing nations

Malaria - Proteomics in malaria reviewed

Malaria Vaccine - Merozoite surface protein antibodies inhibit malaria antibody responses

Measles Outbreaks - Measles outbreak control in adult populations discussed

Measles Risk Factor - Risk of measles transmission low after exposure on airline flight

Measles Vaccine - Clinical significance of measles reviewed

Measles Vaccine - Evolution of measles elimination strategies in the United States

Measles Vaccine - Progress toward measles eradication in the Americas updated

Medicare - Unclassified, FDA-approved drugs administered to outpatients will be reimbursed

Mental Illness - Study of 14 countries finds mental illness is prevalent

Metapneumovirus - Human metapneumovirus recovered from cDNA

Microbial Testing - FDA approves ues of microbiological test as part of drug quality control process

Myelodysplastic Syndromes - FDA approves Vidaza (azacitidine for injectable suspension) for MDS

Nicotine Addiction - List linking smoking to diseases expands

Nicotine Addiction - More effort needed to get low-income smokers to quit

Nicotine Addiction - Research center details why teens are vulnerable to smoking addiction

Non-Hodgkin Lymphoma - FDA accepts Onco TCS new drug application

Nutrition - Americans not eating enough fruits and veggies

Obesity Epidemiology - Increasing obesity rates will lead to higher disability rates

Ophthamology - Ocular inflammation treatment on file with FDA

Osteoporosis - Website helps parents raise strong daughters

Osteoporosis - sNDA submitted to FDA for once-monthly dose of Boniva

Pain Management - FDA gives approval for generic morphine doses

Pancreatic Cancer - Pancreatic islet cell tumors have non-islet origin

Patient Satisfaction - Survey: Canada, U.S. report high level of health

Pharmaceutical Development - Generic versions of two drugs receive FDA approval

Pharmacokinetics - Method to measure kinetics of penicillin thermal decomposition reported

Pneumonia - FDA approves Avelox (moxifloxacin HCI) for community-acquired pneumonia

Pneumovirus - Molecular genetics and pathogenesis of animal pneumoviruses reviewed

Polio - Two African countries focus of effort to interrupt transmission

Polio Vaccine - Seroprevalence of poliovirus antibody among children in Korea reported

Prescription Drugs - Meetings to help Medicare beneficiaries choose discount cards

Prescription Drugs - West Virginia customers experience prescription delays

Prion Disease - Prion protein undergoes alpha- and beta- cleavages of amino-terminus

Quality Assurance - Report shows FDA inspectors found quality-control problems at Wyeth plant

Regulatory Issues - Report finds problems at Wyeth vaccine plant

Sleep Disorders - PD-6735 granted Orphan Drug Status for sleep disorders in blind patients

Smallpox Vaccine - Smallpox DNA vaccine protects primates against lethal monkeypox

Streptococcus - Streptococci from infants with invasive disease characterized

Tissue Regeneration - FDA issues special protocol assessment approval

Tobacco Lawsuit - Judge orders tobacco company to hand over memo

Tobacco Policy - Underhand activities by tobacco companies rife in former Soviet Union

Viral Disease - Biotech company testing possible antidote for bioterrorism viruses

Virology - Hepatitis E virus can replicate in primate cells in vitro

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