Fda Regulations

Mobile App for Lifesaving Technology? Or Regulated Industry?

Alan W. Silberberg | Posted 05.18.2012

Alan W. Silberberg

Is an app a device? Is it a life-saving tool or is it the new shiny toy on your smartphone about which you know nothing about the reliability or specificity of how it works?

People Are Dying of Drug Overdoses, Despite Lifesaving Medications

Erin L. Winstanley, Ph.D. | Posted 05.11.2012

Erin L. Winstanley, Ph.D.

We have waged a war against drugs instead of formulating a science-based response to a public health epidemic for which a life-saving medication is available.

Grossed Out by Pink Slime? Well, Don't Just Sit There

Michael F. Jacobson | Posted 04.13.2012

Michael F. Jacobson

Signs that our food system is broken are all around us. So are the signs that Americans are craving change and want to do something about it.

The FDA Allows What In Our Food?

Posted 03.21.2012

Your food has to reach "Food Defect Action Levels" that have been created by the FDA before the regulator will take action against products with forei...

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

Rosemary Gibson | Posted 04.03.2012

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.

The FDA Fails the Public on Antibiotics Once Again

Andrew Gunther | Posted 03.10.2012

Andrew Gunther

While the FDA's decision to curb the use of cephalosporins in food animal production has been hailed as positive step, forgive me if you don't see me jumping for joy.

FDA Limits Some Antibiotics In Livestock

AP | MARY CLARE JALONICK | Posted 03.05.2012

WASHINGTON — The Food and Drug Administration on Wednesday ordered farmers to limit the use of a type of antibiotics they give livestock because...

Teens and Flavored Cigars. Seriously?

Barbara Greenberg | Posted 01.18.2012

Barbara Greenberg

Cigar use among teens increased by more than 11% from 2000-2010. And the cigars are not the ones that your uncles smoked. The cigars of choice are -- get this -- candy-flavored.

1,200 Retailers Cited For Violating Tobacco Rules

AP | MICHAEL FELBERBAUM | Posted 01.09.2012

RICHMOND, Va. — The Food and Drug Administration said Thursday it has issued about 1,200 warning letters to retailers in 15 states for violating...

Eighty Percent of Vitamin C Is Imported from China. Is it Safe?

Dara O'Rourke | Posted 08.31.2011

Dara O'Rourke

The dangers of an increasingly globalized supply chain for food and drugs are already visible. With imports and scandals rising, and government funding decreasing, the FDA will have to focus their limited resources to protect public health.

Data Exclusivity: Getting the Balance Right

John Horton | Posted 07.19.2011

John Horton

What's the right length for data exclusivity? The current law says innovator drug makers have twelve years; in the European Union, it's ten; and the 2012 budget proposes seven. Who's right?

The Public Health Crisis No One Is Talking About

Sasha Cagen | Posted 06.19.2011

Sasha Cagen

Imagine there is a food additive that slowly poisons you and can even kill you. Now imagine you have no way of knowing whether it is in your foods. Three million American celiacs and I find myself in this situation.

FDA: Agency Must Review Tobacco Products

AP | MICHAEL FELBERBAUM | Posted 05.25.2011

RICHMOND, Va. — The Food and Drug Administration says it must review tobacco products that were introduced or changed over the last four years i...

FDA Would Boost Food Inspections Under New Senate Bill

AP | MARY CLARE JALONICK | Posted 05.25.2011

WASHINGTON — The Food and Drug Administration would have to step up inspections of food plants under legislation the Senate is expected to pass ...

Should the FDA Have Stricter Regulations Around Homeopathic Products?

Christine Escobar | Posted 05.25.2011

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

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 Botox For Migraine Headaches

AP | MATTHEW PERRONE | Posted 11.17.2011

WASHINGTON — Federal health officials approved the wrinkle-smoothing injection Botox for migraine headaches on Friday, giving drugmaker Allergan...

FDA Won't Restrict Cough Syrup

healthland.time.com | By Meredith Melnick | Posted 11.17.2011

The FDA considered imposing an age limit on purchasing cough syrup, due to its abuse among teenagers. But last night, a panel assembled by the FDA vot...

The Myth About Food Safety Legislation and Small Farmers

Carol Tucker-Foreman | Posted 05.25.2011

Carol Tucker-Foreman

Supporters of local and organic food should be substantially reassured that the new food safety legislation working its way through Congress does not place an inordinate burden on small and organic growers.