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 [...]
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. [...]
National Vaccine Information Center Criticizes FDA for Fast Tracking Licensure NVIC Press Release June 27, 2006 MERCK’S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS National Vaccine Information Center Criticizes FDA for Fast Tracking Licensure Washington, D.C. – The National Vaccine Information Center (NVIC) is calling on the CDC’s Advisory Committee on Immunization Practices (ACIP) [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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, [...]
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 approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA’s priority review process–a process for products with potential to provide significant health benefits.
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