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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 7th, 2003

Non-Subscriber - Summaries Only

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

Food-borne Illness - Filtration membrane applied to IR spectroscopic discrimination of bacteria

Mosquito-borne Disease - Genomics spawns novel approaches to mosquito control

Breast Cancer Screening - Cancer registry useful for Florida breast cancer early detection program

Cardiology - Model for computing motion of mechanical heart-valve leaflets developed

Giardiasis - Oral immunization with Giardia duodenalis protein inhibits shedding of cysts

Streptococcus Vaccine - CDCP recommends pneumococcal polysaccharide vaccine for adults older than 65

ADHD - Company works to amend its non-approvable New Drug Application

Allergy Medicine - FDA approval granted for loratadine

Bacteriology - Stannous chloride affects adhesive properties of C. diphtheriae strains

Breast Cancer - Breast cancer detection system receives marketing approval from FDA

Breast Cancer - FDA gives approval for phase III registrational trial for breast cancer drug

Breast Cancer - Kodak gets FDA approval for mammography device

Cloning - FDA urged to base animal cloning policy on long-term research

Cloning - Lots of animals cloned, but nature doesn't make it easy; Monkeys? Forget it

Collaborations - Haemonetics announces intent to sign distribution agreement with French firm

Contraception - A new WHO study shows hormonal male contraception prevents pregnancy

DNA Damage - Mechanism of apoptotic resistance of human osteosarcoma cell line elucidated

Diagnostics - Guidelines for assessing immunotoxicity released

Diagnostics - Imaging company inks agreement with the Rumbaugh-Goodwin Institute

Drug Abuse - Family factors affect drug use by Mexican American teens

Eating Disorder - Pharmacotherapy of eating disorders reviewed

Endocrinology - Effects of aging and stress on hippocampal structure and function described

Environmental Health - Insecticide metabolites determined in human urine by GC-MS

Epilepsy - Medicare reimbursement rates posted for VNS therapy

Finance - Biopharma company announces third quarter 2003 financial results

Finance - Insulin system maker reports loss of $0.08 per share

Finance - Pain medication maker reports royalty income increased 23%

Finance - Seasonale maker reports 41% increase in revenue

Finance - Specialty pharmaceutical company reports record quarterly revenues

Finance - VAP-focused pharmaceutical company increases cash resources, meets milestones

Genomics - NHGRI funds large-scale genomic sequencing project

Glucose Monitoring - FDA clears GlycoMark test for people with diabetes

HIPAA Compliance - MedAptus' Charges In Hand 4.1 released

HIV Diagnostic - Investigational device exemption application submitted for HIV-1 test

HIV Gene Therapy - Gene vector for HIV cleared to begin phase I/II trial

HIV and AIDS Prevention - HIV-related preventive behavior in U.S. improves in many population groups

HIV/AIDS Epidemiology - Children left motherless by AIDS in U.S. drops from 1978 to 1998

Hemolysis - Unfolding of Vibrio cholerae hemolysin induces toxin monomer oligomerization

Hemophilia - Supplement filed for approval of needless device used with Kogenate FS

Hepatitis C Virus - Pharmaceutical company to initiate phase III clinical trials for Viramidine

Immunoglobulin - New IGIV, Gamunex, now available

Influenza - Team developing "Flu Chip" for fast, accurate diagnosis

Injury Prevention - Parents favor speed bumps to protect child pedestrians

Injury Prevention - Parents' input, new license step may cut teen car wrecks

Injury Prevention - UF researchers say speeding associated with gambling, drug use in teens

Insulin Infusion - Animas IR 1200 receives FDA approval

Intravascular Therapy - 510k market clearance granted for catheters with thermal regulation system

Leishmaniasis - Present status of antileishmanial vaccines reviewed

Leukemia Therapy - Cytoreduction may be needed for curative SCT in CML patients

Malaria Vaccine -  P. falciparum SERA protein peptide analogues protect against malaria

Meningococcal Vaccine - Doses of meningococcal C-tetanus toxoid vaccine can be reduced

Mycobacterium - Microfluidic labchip instrument used to identify Mycobacterium species

Occupational Health - Acute occupational disinfectant-related illness among youth reported

Ocular Infections - FDA accepts NDA for ophthalmic anti-inflammatory/antibiotic

Ophthalmology - Groups warn against mobile eye clinics

Parkinson Disease - IND application filed with FDA For AV201

Pediatric AIDS - Potential low-cost options for monitoring disease status described

Pediatric Hypertension - Patient enrollment completed in Altace pediatric clinical trial

Pharmacokinetics - Narapril and Renitec are bioequivalent brands of enalapril

Pharmacy Benefits - MBI and Familymeds announce on-line pharmacy partnership

Pharmacy Benefits - Medica announces affordable drug benefit for Medicare beneficiaries

Policy - AIDS epidemic should be treated as a disaster

Policy - Physician organizations urge Secretary Thompson to defend NIH review process

Premature Menopause - Half of premature menopause and ovarian failure patients still have follicles; can conceive

Preparedness - U.S. plans to grade states' bioterrorism plans

Prescription Drug Importation - Canada cracks down on drugs for Americans

Prescription Drug Importation - North Dakota officials eye prescription drugs from Canada

Proteomics - Perlecan play role in skeletal development and diseases

Regulatory Issues - WHO steps up action against fake medicines

Reimbursement - Medicare to cover annual InSure testing for colorectal cancer screening

Skin Cancer - New and emerging topical approaches for actinic keratoses reported

Substance Abuse - SAMSA: Many substance abusers "not ready" to seek treatment

Television - Physicians to spread word on negative effects of TV, drug ads

Transplantation - Transplantation society releases guide for immunosuppressive drug use

Type 2 Diabetes - Glycemic control monotherapy granted tentative approval by FDA

Vaccine Adjuvant - Natural antibodies and complement are endogenous adjuvants for vaccines

Vaccine Safety - Bioterrorism vaccination is contraindicated in some drug-allergic patients

Ventricular Tachycardia - Implantable cardioverter defibrillator receives FDA approval and CE marking

West Nile Fever - Substantia nigra involved in West Nile virus-induced encephalitis

West Nile Virus - First human trial of West Nile vaccine to begin

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