FDA

The Food and Drug Administration has approved its first digital drug: a pill embedded with a sensor that transmits whether someone has taken it.

Although the approval is a big step for digital medicine, there are concerns about privacy, convenience and cost.

Scott Gottlieb, the Food and Drug Administration commissioner appointed by the Trump administration, has this in common with Michelle Obama: He wants to know what's in the food he eats.

And this, it seems, includes calorie counts.

Now, the FDA has released its guidance on implementing an Obama-era rule that requires chain restaurants and other food establishments to post calories on menus or menu boards. The mandate was written into the Affordable Care Act back in 2010.

What counts as dietary fiber? That's up for debate.

The Food and Drug Administration is reviewing 26 ingredients that food manufacturers use to bulk up the fiber content of processed foods to determine if there's a health benefit.

If you're a nutrition-label reader, the list includes some familiar-ish sounding ingredients — such as inulin, which is often sourced from chicory root.

Gene therapy, which has had a roller-coaster history of high hopes and devastating disappointments, took an important step forward Thursday.

A Food and Drug Administration advisory committee endorsed the first gene therapy for an inherited disorder — a rare condition that causes a progressive form of blindness that usually starts in childhood.

The recommendation came in a unanimous 16-0 vote after a daylong hearing that included emotional testimonials by doctors, parents of children blinded by the disease and from children and young adults helped by the treatment.

Valerie Green is still waiting to be cured.

The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn't qualify yet for the Medicaid program's criteria for treatment with a new class of highly effective but pricey drugs.

The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.

Every year about 130,000 people in the U.S. are hospitalized with a foodborne illness, and 3,000 people die.

To protect against this, the Food and Drug Administration inspects facilities that produce and handle food to ensure safety and compliance with regulations.

But a new report from the Department of Health and Human Services' Office of Inspector General raises some red flags about the inspections program.

FDA Moves To Rein In Drugmakers' Abuse Of Orphan Drug Law

Sep 13, 2017

The Food and Drug Administration is changing the way it approves medicines known as "orphan drugs" after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

Matt Markgraf, WKMS

Members of the Kentucky Tobacco Research Board are considering potential future uses for burley and dark leaf tobacco grown in the bluegrass state. Discussion at Monday’s meeting addressed proposed FDA regulation of nicotine levels in tobacco products.

The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

Given the fact that "New of Kopi Jantan Tradisional Natural Herbs Coffee" has been marketed as a "male enhancement" product, it might be fair to assume that consumers who plucked the instant coffee off store shelves had a clear idea of its intended effects.

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