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Fda Approval

Needless Delay for a Medicine That Could Save Kids' Lives

Tracy Seckler | Posted 03.05.2014 | Healthy Living
Tracy Seckler

My advisors tell me to keep working the system, to keep the door cracked open by giving FDA officials opportunities to "save face" and encourage a new drug application for eteplirsen. But I cannot allow any more time to go by.

A Door Opens for Women's Right to Sexual Pleasure, Let's Hope the FDA Doesn't Close It

Serra Sippel | Posted 03.25.2014 | Women
Serra Sippel

The global community's response to sexual dysfunction should be equal for women and men, but it is not. This year marks 16 years since the introduction of Viagra. Today, the market includes more than 20 drugs to address male sexual dysfunction -- and not a single one for women.

The Future of Testing Your Genetic Future

Robert Klitzman, M.D. | Posted 02.10.2014 | Healthy Living
Robert Klitzman, M.D.

This week, 23andMe, the Google-backed DTC genetic test company, stunned many observers by agreeing to stop sales of its $99 genetic test kit online, saying it will now release only ancestry information and raw data without interpretation.

Medtronics Manipulates Safety Data -- When a Fine Should Become a Crime

Spencer Aronfeld | Posted 08.11.2013 | Business
Spencer Aronfeld

It is perfectly legal and common for physicians to prescribe medication and medical devices for "off-label" use. But the FDA prohibits manufacturers from directly promoting the unapproved use of their products.

The Patient Choice Act - Providing Choice Instead of Death

Jonathan Agin | Posted 07.02.2013 | Impact
Jonathan Agin

As time went by during my daughter Alexis' long thirty-three month battle, we found out that her tumor was growing. We found ourselves in Manhattan seeking to gain enrollment in what looked to be a potentially promising trial. But after preliminary tests we were told that Alexis was ineligible.

Daily Pill Approved For Painful Sex During Menopause

AP | Posted 04.01.2013 | Fifty

WASHINGTON -- The Food and Drug Administration on Tuesday approved the first pill-based drug for women who experience pain during sex because of menop...

3 Steps the FDA Can Take in 2013 to Show It Is Protecting Americans From Harm

Peter Lehner | Posted 03.19.2013 | Green
Peter Lehner

For as welcome as the new food safety programs are, the FDA is still plagued with problems. It moves at a glacial pace in the face of pressing health hazards, like its three-decade-long refusal to act on its own findings that the use of antibiotics in livestock feed threatens human health.

The FDA's Dangerous Death Race

Spencer Aronfeld | Posted 01.28.2013 | Healthy Living
Spencer Aronfeld

As a Miami lawyer who sues prescription drug manufactures, I strongly urge the FDA to slow down and not allow innovation and corporate profit to outweigh consumer safety.

No More Skipping Your Medicine -- FDA Approves First Digital Pill

XPRIZE | Posted 10.09.2012 | Health News
XPRIZE

By Peter Murray Contributing Writer, Singularity University. The Food and Drug Administration has just approved a device that is integrated into pill...

Regulators Approve Take Home HIV Test

AP | MATTHEW PERRONE | Posted 09.02.2012 | Business

WASHINGTON (AP) — Americans will soon be able to test themselves in the privacy of their own homes for the virus that causes AIDS, now that the Food...

A Novel Way to Create American Jobs: Brought to You By the Medical Device Industry and Congress

Rosemary Gibson | Posted 04.03.2012 | Politics
Rosemary Gibson

At stake is whether medical devices that are put in your body, cardiac stents, heart valves, knee and hip implants, among others, will be subject to safety tests in humans before they are approved by the FDA.

'Chelsea' Round Table Talks Hangover Pill

Posted 02.28.2012 | TV

Just in time for New Year's Eve revelers, the FDA has approved what "Chelsea Lately" (Weeknights, 11 p.m. EST on E!) dubbed "the other morning after p...

Throwing Biotech Lies at Tomatoes - Part 1: Killer Tomatoes

Jeffrey Smith | Posted 05.25.2011 | Home
Jeffrey Smith

http://www.responsibletechnology.org/blog/552 Remember the pictures of the fish tomatoes? For years they were an unofficial emblem of the anti-GMO m...

Throwing Biotech Lies at Tomatoes - Part 2: The Liars

Jeffrey Smith | Posted 05.25.2011 | Home
Jeffrey Smith

http://www.responsibletechnology.org/blog/558 < Read Part 1 I write about the Flavr Savr in Genetic Roulette: The Documented Health Risks of Genetic...

Should the FDA Have Stricter Regulations Around Homeopathic Products?

Christine Escobar | Posted 05.25.2011 | Home
Christine Escobar

Homeopathic products are not regulated by the FDA in quite the same way as other over-the-counter (OTC) drugs are.

Rat Hairs? Mold? What The FDA Say Is OK To Eat (PHOTOS)

Posted 05.25.2011 | Home

Rat hairs in your peanut butter sandwich and insect fragments in your pasta sauce? Yuck. Yet according to the Food and Drug Administration (FDA) these...

FDA Approves Drug For Multiple Sclerosis

AP | MATTHEW PERRONE | Posted 11.17.2011 | Healthy Living

WASHINGTON — Federal health regulators have approved the first pill to treat the underlying causes of multiple sclerosis, a debilitating nervous...

Close the FDA Approval Gap

Steven K. Galson, MD, MPH | Posted 11.17.2011 | Healthy Living
Steven K. Galson, MD, MPH

Even though our system of pharmaceutical review and approval is regarded as the most effective in the world, there exists an incredible -- and potentially deadly -- loophole: unapproved drugs.

Cervix Not Required: An Interview with Dr. Adina Nack

Abby L. Ferber | Posted 11.17.2011 | Healthy Living
Abby L. Ferber

Last Friday, the FDA approved the HPV vaccine for use in boys and men. Why is Gardasil only now being approved for males, when it was approved three years ago for females?

Barcode On Your Broccoli: FDA To Approve Laser Labels For Vegetables

Slashfood | Posted 05.25.2011 | Technology

The FDA is expected to approve laser-etching of fruits and vegetables in the next month or so, paving the way for produce "tattooed" with product info...

FDA Needs To Dismiss Former Monsanto Counsel

Samuel S. Epstein | Posted 05.25.2011 | Green
Samuel S. Epstein

The recent appointment of Michael Taylor as FDA's Senior Food Safety Advisor is of major public health concern since he is a former counsel for Monsanto who argued rBGH was safe.

Antibiotic-Free Meat: Is the FDA Finally Catching Up to the American Consumer?

Jennifer Grayson | Posted 05.25.2011 | Green
Jennifer Grayson

The beauty of our system is that when government lags behind, we as American consumers still have the power to direct the marketplace by the products we buy -- or don't buy.

Setting Time Bombs in Our Chests: Our Unreliable FDA

Ian Millhiser | Posted 05.25.2011 | Politics
Ian Millhiser

Lacking sufficient resources to monitor thousands of medical devices on their own, the FDA relies on the medical device industry itself to disclose potential problems in the devices it regulates.

Just How Corrupted Has American Medicine Become?

Bruce E. Levine | Posted 05.25.2011 | Business
Bruce E. Levine

Drug-company corruption of American medicine is of course not news. What is news is that such corruption has become so egregious, so transparent, and so embarrassing.

New Fillers For Those Stubborn Wrinkles

Dr. Anne Chapas | Posted 05.25.2011 | Style
Dr. Anne Chapas

The latest generation of injectable fillers has been shown to stimulate collagen growth in order to replace the underlying skin scaffolding and create softer and more natural contours.