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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . March 21st, 2004

Non-Subscriber - Summaries Only

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

Anthrax - New assay better than ELISA for measuring antibodies to anthrax toxins

HIV/AIDS Diagnosis - New automated ELISA reduces detection time of HIV-specific antibodies

Meningitis - Slide agglutination discrepancies resolved in Neisseria meningitidis

Mycobacterium -  Mycobacterium vanbaalenii PYR-1 degrades benzo[a]pyrene

Preventive Medicine - Practical and regulatory issues in prevention studies outlined

Rabies Virus - Detection of rabies virus by PCR difficult due to virus heterogeneity

Achondroplasia - Defective lysosomal targeting of FGFR3 leads to achondroplasia

Alzheimer Disease - Evaluation of disease-modifying therapies in Alzheimer disease reviewed

Antimicrobials - Extension of NCCLS guidelines is not warranted

Aortic Aneurysm - PMA accepted by FDA for stent graft

Autoimmune Disease - Light chain-expressing B cells produce self-reactive antibodies

Avian Influenza - WHO says bird flu in house cats unlikely to increase risk of human risk

Behavior - Adolescent brains show reduced reward anticipation

Biotechnology - U.S. calls European fears over biotech crops an "overreaction"

Botulinum Toxin - Uptake of botulinum neurotoxin into cultured neurons explored

Business & Finance - Cancer therapeutics company reports fourth quarter and full year 2003 results

Business & Finance - Generics maker reports revenue increases, files eight new INDs/ANDAs in 2003

Business & Finance - Q2 revenues up 9% over same quarter last year for ion-technology company

Cancer Therapy - IND application filed for anticancer agent XL647

Canker Sores - OraDiscA NDA accepted for FDA filing

Colon Cancer - Erbitux receives FDA approval

Colon Cancer - FDA approval granted for EGFR pharmDx

Contraception - FDA extends Plan B emergency contraceptive PDUFA date

Correctional Healthcare - Elderly inmates swell U.S. prisons, driving up healthcare costs

Counterfeit Prevention - New RFID inventory solution meets FDA anticounterfeiting recommendations

Dengue Fever - Hematocrit, platelet levels do not predict shock in children

Diarrhea - FDA grants fast-track status Ramoplanin

Drug Development - FDA agrees to manufacturing plans for ISA247

Enlarged Prostate - FDA approval granted for Prolieve Thermodilatation system

Exercise - American youth more physically active, survey shows

Facilities - CDC granted $250 million appropriation to improve aging labs

Generic Drugs - FDA approves ANDA for generic glyburide/metformin HCl

HIV/AIDS Funding - Bush unveils emergency plan in fight against AIDS

HIV/AIDS Prevention - AIDS threat growing throughout Europe

HIV/AIDS Treatment - "Universal access" to HIV/AIDS treatment pledged by Europe, Central Asia

HIV/AIDS Treatment - Studies: Potential for Invirase plus ritonavir and protease inhibitors

Haemophilus - Metabolic indicator used to measure Haemophilus influenzae activity

Healthcare Coverage - U.S. HHS commissioner hasn't given up hope on drug pooling plan

Healthcare Disparities - U.S. HHS issues unedited version of earlier disparities report

Hearing Aids - VA awards contract to provide hearing care services in Florida, Georgia, Texas

Hemolytic Disease - FDA approves Rhophylac for prevention of hemolytic disease

Hepatology - Hepatopulmonary syndrome is concern for the anesthetist

Hormone Replacement Therapy - Scientists raise caution about effects of HRT on hearing

Infant Mortality - Iraqi healthcare effort to focus on infant mortality

Infectious Diseases - Tubercin testing continues at University of Colorado's Health Science Center

Influenza - Flu season is seen as moderately severe

Influenza - Influenza epidemics in France and United States follow similar patterns

Information Technology - NICHD selects Booz Allen Hamilton to support National Children's Study

Kidney Damage - FDA clears FlowMedica Bifurcated Infusion System for marketing

Knowledge, Attitudes, and Behaviors - Americans still don't get it when it comes to health, survey shows

Measles Vaccine - Edmonston-Zagreb measles vaccine induces cellular and humoral immunity

Meningococcal Vaccine -  Neisseria meningitidis IgG concentrations assigned to reference sera

Multiple Sclerosis - Antegren to be submitted for review based on 1-year data

Narcolepsy - FDA grants tentative approval for manufacturing and marketing of Modafinil

Needle Safety - EPA changes guidelines on disposal of medical needles and syringes

Non-Hodgkin Lymphoma - Non-Hodgkin lymphoma study assesses pesticide levels in carpet dust

Obstetrics - FDA panel backs Accutane registry to prevent drug's use by pregnant women

Occupational Health - CDC publishes new workbook to protect health care workers from sharps injuries

Occupational Health - Focus on disability-adjusted life-years can reduce disease burden

Oral Health - Five billion people worldwide suffer from tooth decay

Osteoporosis - FDA accepts ANDA filing for Calcitonin-Salmon Nasal Spray

Pediatric Obesity - Many kids aware of CDC obesity campaign

Pediatrics - Racial differences in infant death causes in United States reported

Poliomyelitis - Emergency polio immunization campaign hampered by vaccine boycott

Poliomyelitis - Nigeria's neighbors guard against spreading polio outbreak

Prescription Drug Importation - McClellan to lead study of drugs from Canada, over objections

Prostate Cancer - IND application filed to test Modrenal in second indication

Sepsis - NIAID bioterrorism grant to fund a new plasmapheresis device

Sexual and Reproductive Health - E-mail used to alert sex partners of STD exposure

Sexual and Reproductive Health - One of two will have STD by age 25

Smallpox - Smallpox array set developed with CDC completed

Smallpox Vaccine - Physicians decline smallpox vaccination due to inadequate benefits

Smallpox Vaccine - Study shows no vaccinia viremia after smallpox vaccination

Spinal Surgery - Company launches enhanced CD HORIZON spinal system

Surgical Sealant - Biomaterials company completes DuraSeal study enrollment

Systemic Lupus Erythematosus - Riquent NDA accepted for review by FDA

Tobacco Marketing - U.S. government tries to prove tobacco companies lured children

Tremors - FDA gives guidance on special protocol assessment for Altropane study

Tuberculosis Vaccine -  M. leprae Hsp65-encoding plasmid DNA induces anti-mycobacterial immunity

Vitamins - FDA approves multivitamin bulk package

West Nile Virus - Infants whose mothers were infected during pregnancy need careful evaluation

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