Analysis of decades of drug approvals by a Harvard Research team, published in the March 27th New England Journal of Medicine, provides the first scientific evidence of what many have come to suspect. Congress-mandated deadlines that control the FDA review of new medications may … [Read more...] about Deadlines May Affect FDA Decision Process
Archives for March 2008
FDA Identifies First Steps in Requirements for Safety Plans
FDA News FOR IMMEDIATE RELEASE March 27, 2008 Media Inquiries: Chris DiFrancesco, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics New FDAAA requirements … [Read more...] about FDA Identifies First Steps in Requirements for Safety Plans
FDA To Review Merck’s Application To Expand HPV Vaccine Gardasil’s Approval To Older Women
FDA has granted priority review status to Merck's application to expand marketing of its human papillomavirus vaccine Gardasil to women ages 27 to 45, the company said Wednesday, Reuters reports. The designation means that an FDA decision could come within six months, according … [Read more...] about FDA To Review Merck’s Application To Expand HPV Vaccine Gardasil’s Approval To Older Women
What Was Old Is New Again
Women Turning to Natural Methods of Birth Control Young women are turning to old ways to manage fertility cycles. Amanda Zamani of Asheville, N.C., never really liked hormonal birth control and its effects on her body. She had a hard time remembering to take a birth-control pill … [Read more...] about What Was Old Is New Again
One in Four Girls…
Nationally Representative CDC Study Finds 1 in 4 Teenage Girls Has a Sexually Transmitted Disease "3.2 Million Female Adolescents Estimated to Have at Least One of the Most Common STDs" Chicago (March 11, 2008) – A CDC study released today estimates that one in four (26 … [Read more...] about One in Four Girls…