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Monthly Archives: June 2006

MERCK & CO, GARDASIL® Product Information

Patient Information about GARDASIL® (pronounced “gard-Ah-sill”)
Generic name: [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]
Read this information with care before you or your child gets GARDASIL*. You or your child will need 3 doses of the vaccine. It is important to read this leaflet when you receive each dose. This leaflet does not […]

MERCK’S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS

National Vaccine Information Center Criticizes
FDA for Fast Tracking Licensure
for immediate release
June 27, 2006
Washington, D.C. - The National Vaccine Information Center (NVIC) is calling on the CDC’s Advisory Committee on Immunization Practices (ACIP) to just say “no” on June 29 to recommending “universal use” of Merck’s Gardasil vaccine in all pre-adolescent girls. NVIC maintains […]

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring
The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency’s oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency’s approach […]

Breast Cancer

Every three minutes a woman in the United States is diagnosed with breast cancer.
In 2006, an estimated 212,920 new cases of invasive breast cancer are expected to be diagnosed, along with 61,980 new cases of non-invasive breast cancer. And 40,970 women are expected to die in 2006 from this disease.(1.)
Breast cancer is the leading cancer […]

Human Papillomavirus (HPV) and Genital Warts

What is human papillomavirus (HPV)?
Human papillomavirus (pronounced pap-ih-lo-ma-vye-rus) is also called HPV. It is a virus that includes more than 100 types, over 30 of which are sexually transmitted. The types of HPV that infect the genital area are known as genital HPV. Most sexually active people will have HPV at some point in their […]

Cervical Cancer

What is cervical cancer?
Cancer is a disease in which certain body cells don’t function right, divide very fast, and produce too much tissue that forms a tumor. Cervical cancer is cancer in the cervix, the lower, narrow part of the uterus (womb). The uterus is the hollow, pear-shaped organ where a baby grows during a […]

FDA Press Release — HPV (human papillomavirus)

What is HPV?
HPV (human papillomavirus) is a sexually transmitted virus. It is passed on through genital contact (such as vaginal and anal sex). It is also passed on by skin-to-skin contact. At least 50% of people who have had sex will have HPV at some time in their lives.
Why haven’t I heard of HPV?
HPV […]

FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus

Rapid Approval Marks Major Advancement in Public Health
FDA Press Release
June 8, 2006
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is […]