Tag Archives: drug approval

These FDA apps can be helpful for reporting and story ideas

If you are familiar with  Drugs@FDA, you know that the website allows you to quickly look up a drug by its name (brand), the active ingredient (generic), or application number. But if you frequently work on the go or need to look up something quickly while away from your computer, you now can download the FDA’s new app, Drugs@FDA Express (iOS/Apple and Android/Google), to see much of the same information.

Released in late March, the app is pretty basic, but often that’s the best kind of app. It loads quickly, isn’t overly cluttered and has simpler user-friendly interface. The opening page is straightforward. Continue reading

How often do drugs obtaining accelerated approval fulfill their potential?

Image: Seattle Genetics

If a new drug appears to show remarkable success in curing patients with a specific, aggressive cancer type that has few or no other effective treatments, there can be a compelling reason to get it on the market as soon as possible.

However, evidence requirements for drugs to receive accelerated FDA approval often rely on surrogate endpoints. That’s particularly true for conditions such as cancer where the ideal primary endpoint — survival — isn’t possible to assess in a short period. Continue reading

FDA documents for most-popular drugs not online

Nancy Watzman, writing for the Sunlight Foundation Reporting Group, has found that, because the Food and Drug Administration only makes approval background documents available for drugs approved after 1997, safety and efficacy information for nine of the 25 most-prescribed drugs is not available online.

The article points out that doctors base their treatment decisions on information in peer-reviewed articles, where drug companies have little incentive to publish negative information. The studies the FDA uses to make approval decisions, however, may have more complete and balanced information that would be useful to doctors and consumers.

Watzman reports that the FDA apparently receives such documents electronically, then prints them out, redacts them by hand (using white out!) and then scans them and saves them as PDF documents that are not searchable.

The report includes a list of the 25 most-prescribed drugs and highlights those for which FDA review documents are available online.