This isn’t the first time the issue has drawn public interest. In 2011, the Institute of Medicine (IOM) reviewed the FDA’s 510(k) clearance process for medical devices, saying it should be ...

The U.S. Food and Drug Administration has recalled thousands of bottles of the antidepressant duloxetine over the presence of a toxic chemical. According to an Oct. 10 notice from the agency, the ...

Depending on age, the IOM says that men typically eat about 200 ... Experts say that until the FDA takes a stand on the carbohydrate issue, it's up to consumers to educate themselves on how ...

Among its recommendations, the IOM report stated the following: FDA should increase attention to the safe use of drugs in both pre- and postmarketing processes through the following actions ...

In 2006, the Institute of Medicine (IOM) published a report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” meant to highlight flaws in the FDA drug approval ...

There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in the form of a Warning Letter, an Untitled Letter, or an “It Has Come ...

MiMedx has said the product belongs in a category that permits its sale and use without FDA scrutiny. But in a warning letter late last year, the FDA disagreed. In that warning letter, FDA ...

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 ...

The "FDA Inspection Preparedness and Compliance" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...

The IOM report concluded that local complications ... One of these studies, conducted by FDA scientists, found a statistically significant link between ruptured silicone gel implants and ...

Improving the Patient Financial Experience Throughout the Patient Journey While many healthcare providers believe that improving the patient financial experience is a critical step for their ...