Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA. Form FDA 1572 is the contract between ...

The Council on Foreign Relations (CFR) is an independent, nonpartisan membership organization, think tank, and publisher dedicated to being a resource for its members, government officials ...

What is an FDA Calendar? Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment ...

People with obesity who took the highest dose of the drug lost 21 percent of their total body weight, according to a randomized-controlled trial published in the New England Journal of Medicine.

Applications for proposed drug products where the rate (21 CFR 314.54(b)(2)) and/or extent (21 CFR 314.54(b)(1)) of absorption exceed, or are otherwise different from, the 505(j) standards for ...

For example, you should consider whether the choice of population results in an equitable distribution of the burdens and benefits of research (45 CFR 46.111(a)(3); 21 CFR 56.111(a)(3 ... data (for ...

Apple AirPods Pro 2 can soon be used as hearing aids, after they received Food and Drug Administration (FDA ... and treating hearing loss, which is part of overall health." ...

Whether you have a stand-alone drug plan or a Medicare Advantage plan that covers prescription medications, Part D drug coverage has four payment stages or phases. Here are two examples that ...

The Pill Identifier helps you spot FDA-approved medications only. It doesn’t identify dietary supplements (for example, most vitamins and herbals), illegal drugs, or drugs from outside the ...

A potential FDA proposal would label Goldfish “medium” in saturated fat and sodium. (The placement and size of any U.S. label has yet to be determined.) The same product would bear stop-sign ...

But, it wasn't until 1930 that the name, the Food and Drug Administration, was officially adopted. The agency is part of the Department of Health and Human Services and has more than 18,000 ...

13 (UPI) --The U.S. Food and Drug Administration has authorized software ... at treating small gaps in the macula, the central part of the eye's retina, which can cause distorted or blurred ...