The Food and Drug Administration said Monday that it will require German drug maker Bayer AG to undertake new safety studies on its permanent birth-control device Essure, after thousands of women complained about suffering complications from the controversial implant. The agency also plans to require a “black box” label warning about the device’s potentially serious side effects, plus a checklist for doctors to discuss potential risks with patients.
Tag: FDA
FDA: Califf Wins Unanimous Support of Senate Committee
The Senate Health, Education, Labor, and Pensions Committee voted unanimously Tuesday in a voice vote to approve the nomination of Robert Califf, MD, as FDA commissioner.
That Cool New Female Viagra Is a Bust
The drug, flibanserin, known commercially as Addyi, was developed by a German drug firm and acquired by a small North Carolina drug company that in turn was bought by Canadian pharma giant Valeant for a billion dollars in cash a day after the FDA approved its use by women suffering from low libido. That FDA approval came in the wake of a studied PR campaign by the North Carolina company, Sprout, that involved charging the FDA with sexism and busing dozens of women to FDA hearings where they offered tearful testimony about the havoc not wanting to have sex was wreaking on their lives. According to Sprout, more than 40 percent of all women are experiencing sexual dysfunction.
INVOcell Intravaginal IVF Embryo Incubator FDA Approved
In-vitro fertilization is a laborious process that requires careful preparation and incubation of embryos. INVO Bioscience out of Medford, Massachusetts just received FDA de novo approval to introduce its INVOcell intravaginal culture system that allows women to use their bodies as the incubator.
FDA to Review Safety of Controversial Women’s Sterilization Device
On Thursday, the Food and Drug Administration will hold a public hearing to consider the stories of women like Hughes, who claim they have been seriously harmed by the permanent birth-control device. The agency called the meeting earlier this year amid mounting reports of complications linked to the device — more than 5,000 at last count — and a long-running social media campaign by women who want Essure pulled from the market.
FDA Vulnerability Revealed
Loud applause erupted when an advisory panel recommended in early June that the US Food and Drug Administration (FDA) approve the first medication to treat low libido in women. Many more must have cheered when the FDA followed the committee’s advice and approved the prescription drug, which will go by the name Addyi, on 18 August.
FDA to Again Consider Drug Aimed at Women’s Sexual Dysfunction
The Food and Drug Administration said that safety concerns outweighed any benefits, and, in 2013, again rejected the drug for approval.The manufacturer, Sprout Pharmaceuticals resubmitted an application for approval in February with additional safety studies.And on Thursday, an advisory committee of the FDA will again examine the risks and rewards of the drug. Their vote could influence the final FDA decision, due in August.
Sprout Pharmaceuticals’ ‘Female Viagra’ Pill Again Seeks FDA Approval
Not in the mood? Flibanserin, a little pink pill that increases a woman’s libido, is seeking FDA approval for the third time.
Breast Cancer Drug Proven Effective Fertility Treatment
A recent study reveals Femara, a medication that’s FDA-approved to treat breast cancer, may be more effective than current fertility drugs for some women who suffer from PCOS.
HPV Test Approved for Cervical Cancer Screening
The FDA announced approval Thursday of the human papillomavirus DNA test as a primary screening method for cervical cancer.