News and Events - 14 Feb 2012

Stryker's Wingspan brain stent gets a date with the FDA

13.02.2012 23:53:44

The FDA sets a date to review data on Stryker's Wingspan brain stent, which has been challenged by patient groups and the former head of the Center for Devices & Radiological Health.

The FDA's neurological devices panel will review clinical data from trials of Stryker's (NYSE:
SYK Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.

The panel plans to consider pre-market and post-market data about the device, including the Gateway PTA balloon catheter and stent delivery system, to address concerns that Wingspan may lead to heightened risk of stroke or death.

News Well,
Food & Drug Administration (FDA ,
Neurovascular repair,
Recalls,
Regulatory/Compliance,
Stents

read more

http://www.massdevice.com/news/strykers-wingspan-brain-stent-gets-date-with-fda#comments

Rick Warren, please report to jail

rss@dailykos.com (kos

13.02.2012 21:46:04

Grandstander. (Tami Chappell/Reuters

Rick Warren, freaking out over the new birth control policy:

I'd go to jail  rather than cave in to a govement mandate that violates what God commands us to do. Would you? Acts 5:29

—
@RickWarren via web

He's so principled!

Except if he's really so principled, and if he's really so resistant to this policy, why hasn't he actually opposed it and sent himself to jail yet?

You see, Warren's ministry is located in Lake Forest, California (Orange County . And a birth control mandate
has been law in California for a long time. Since 1999, actually.

Cal. Insurance Code § 10123.196 and
Cal. Health & Safety Code § 1367.25 (1999 require certain health insurance policies that already cover prescription drugs to provide coverage for prescription contraceptive methods approved by the FDA. Religious employers can request health insurance plans without coverage of approved contraceptive methods that are contrary to the employer’s religious tenants. (
AB 39

Now, California allows churches to opt out, but so does the federal one. In fact, the federal law
was modeled after the exemption offered by California and other states.

More than half the states have similar "contraceptive equity" laws on the books, many with religious exceptions similar or identical to the one included in the administration's regulation.

That's no accident. "The HHS rule was modeled on the exceptions in several state laws, including California, New York and Oregon," says Lipton-Lubet of the ACLU.

The Catholic Church challenged the California law and failed with a 6-1 drubbing at the California Supreme Court.

So given that Warren is willing to go to jail to fight this law, why hasn't he already gone to jail to fight the California one? He's only had 13 years to do so.

So let's have a little fun:
sign the petition asking Rick Warren to report to jail.

Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks

12.02.2012 3:14:00

Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED . The active drug ingredient is not listed on the label for these products.

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply

13.02.2012 22:00:00

The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.

Walnuts help protect against prostate cancer, osteoporosis, and CHD, but the FDA does not want you to know

13.02.2012 9:00:00

Unlike pharmaceutical drugs, natural, whole foods are packed with synergistic nutrients that work together in unity to provide a plethora of health benefits without causing negative side effects -- and walnuts are no exception! A new study published in the British Journal...