Posts Tagged ‘FDA’

Semaglutide Approved for Type 2 Diabetes

December 6, 2017 — Late yesterday, a new, once-weekly injection for type 2 diabetes cleared the hurdle of FDA approval for sale. Semaglutide, will be available early next year in a familiar pen injection device. It will come in two doses: 0.5 and 1.0 mg once weekly. For people with type 2 diabetes it’s great to have a once-weekly […]

Guest Post: Where Is FDA Going with Nicotine and Tobacco?

November 14, 2017 — At the end of July, FDA Commissioner, Scott Gottlieb, and his Center for Tobacco Products (CTP) Director, Mitch Zeller, announced a commitment and vision to dramatically change the impact of tobacco in the US. To understand how far-reaching this plan is, consider the following basics on the state of nicotine policy and science. 1. As a result of […]

Nutrition Facts Labels: Delay, Delay, Delay

October 2, 2017 — Almost five years. That’s how long most businesses can wait before they tell consumers how much sugar they’re adding to food products. The FDA announced Friday that they were adding another year and a half to the original deadlines announced in 2016 when Michelle Obama unveiled updated Nutrition Facts labels. Companies with less than $10 […]

Boon or Bane? The FDA Cardiovascular Safety Hurdle

July 29, 2017 — Almost ten years ago, FDA set a new hurdle for approving new diabetes drugs. Before one of these new drugs could be approved, the sponsoring company would need an expensive cardiovascular safety study. How expensive? The price tag might run as high as a billion dollars. FDA laid this same requirement on new obesity drugs, […]

Delaying, Not Dropping, the Nutrition Facts Label Update

June 24, 2017 — A few weeks ago, the FDA announced an indefinite delay in the new Nutrition Facts label. This label discloses what’s in every food product sold in the U.S. It would — for the first time ever — give consumers information about how much added sugar is in a product. Howls of Protest When this delay surfaced, howls […]

A Stent for Obesity Progressing into Larger Trials

May 1, 2017 — Making progress with medical devices to treat obesity is a tedious business. And it comes with many ups and downs. But with a more reasonable pathway for FDA approvals these days, more entrepreneurs are trying to advance their ideas. In the latests news, the folks developing a hunger-curbing stent for obesity have raised $2.1 million […]

Health Claims Handy for Confusing Consumers

April 30, 2017 — What does it mean when a food label says the product is healthy? For the last six months, more than a thousand public comments have poured into FDA. Two answers rise to the top. Health claims on a food label seem to be good for a bump in sales and for confusing consumers. Peculiar Advice […]

A Steady Climb in Obesity or a Blockbuster Breakthrough?

April 29, 2017 — Making progress in obesity care continues to be a slow and steady business. Nearly 100 million Americans have this complex chronic disease. But it’s so stigmatized that most people don’t really want to think about it – let alone seek care. But progress continues, with a steady climb on all fronts. News from Novo Nordisk – now […]

Really? FDA Should Slow Down?

April 8, 2017 — Here’s a news flash you don’t see every day. Industry says FDA should slow down. Usually drug and medical device companies are complaining that the agency doesn’t move fast enough. Food companies now are saying that FDA shouldn’t move so fast on requiring new and improved nutrition labels on food products. FDA Commissioner Nominee “Delighted” to Consider Slowing […]

Setting a Higher Bar for Dietary Supplements

April 5, 2017 — A remarkable collaboration is taking shape to set a higher bar for the quality and safety of dietary supplements. This week in Washington the Dietary Supplement Quality Collaborative (DSQC) brought together people from the supplement industry with consumer advocates, health professionals, and scientific organizations. This group has been taking shape over the last year. The shared […]