In May, America’s Food and Drug Administration approved Trak, a new “male fertility testing” system. It looks like a cross between a frisbee, a clock and a Cuisinart blender. The Trak website announces that it is “like a Fitbit for sperm”.
Tag: Drug Administration
DIY Sperm Test to Hit the Market this Fall
A semen centrifuge is the newest direct-to-consumer fertility device on the market. The Trak, a desktop gadget that measures a man’s sperm count, was approved by the Food and Drug Administration earlier this month for consumer use.
Zika Vaccine Approved for First Human Testing
Two companies announced Monday that they have received the first approval to test a Zika vaccine on humans. While the approval from the Food and Drug Administration is early in the long process of approving a vaccine for widespread use, it is a step forward in finding a vaccine for the virus, which has become a global health emergency.
The FDA Just Removed One Of Anti-Abortion Lawmakers’ Favorite Talking Points
Thanks to a policy change from the Food and Drug Administration announced on Wednesday, it may get harder for anti-choice lawmakers to rely on unscientific information to restrict women’s access to the abortion pill.
FDA to Require “Black Box” Warning, But Leaves Controversial Essure Implant on Market
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.
Infertility Treatments, in Your Home
Many would-be parents are turning to at-home products to help them conceive—before, during and after seeking professional treatment for infertility. The growing do-it-yourself arsenal ranges from devices that mechanically assist the uniting sperm and egg, to tests that diagnose what’s going wrong. Some are Food and Drug Administration approved; some are MacGyver-esque uses for ordinary household items.
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.
Here’s What Sexperts Think About Female Viagra and Why You Shouldn’t Call It That
When news broke on August 18 that the Food and Drug Administration approved Addyi, the pill that is being incorrectly referred to as the “female Viagra,” it might have seemed like an obvious feminist win. Viagra has been around since 1998, but there hasn’t been anything remotely comparable on the market for women. Addyi is supposed to alleviate female hypoactive sexual desire disorder (or lack of sexual desire). But as we’ve reported, women on Addyi experienced an increase of only one sexual event per month during clinical trials.
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.
‘Viagra for Women’ Gets Push for F.D.A. Approval
Is sexual desire a human right? And are women entitled to a little pink pill to help them feel it?Those questions are being raised in a campaign that is pressing the Food and Drug Administration to approve a pill aimed at restoring lost libido in women. The campaign, backed by the drug’s developer and some women’s groups, accuses the F.D.A. of gender bias for approving Viagra and 25 other drugs to help men have sex, but none for women.