Tag Archive

The following is a list of all entries tagged with FDA:

Consumer Protection

Filed in Advertising/Media, Research, Safety, Statistical Analysis, March 18, 2008, 9:54 pm by Mariano DiFabio , ,

As I was leafing through my March 2008 issue of Pharmaceutical executive, I noticed a focus on consumer protection in the articles I was reading. I’m not sure if it was intentional, but I thought it an interesting topic to mull on for a while, especially given that the state of the economy seems [...]

Ironing Out the Wrinkles

Filed in General, Legal, Personal Health, Research, February 8, 2008, 11:59 pm by Mariano DiFabio , ,

It’s late, and I’m sitting here at squinting at my computer screen most likely because I’ve positioned it too far away from my eyes. At least, that’s what I keep telling myself to make myself feel better.
I believe at some point in my life I will need glasses. I’ve been lucky so far, [...]

Need Money, Will Warn of Dangerous Drugs

Filed in General, January 18, 2008, 12:20 pm by Mariano DiFabio , ,

The FDA was once identified as a gold standard of government agencies, taking its responsibility to the public safety very seriously. It was a key player in mitigating some potentially disastrous events in our short pharmaceutical history, as I explored in, “A Brief FDA History Lesson.” In recent months, however, it has come [...]

FDA Balancing Act

Filed in Clinical Trials, Legal, November 16, 2007, 10:55 pm by Mariano DiFabio

The Food and Drug Administration (FDA) has come under a lot of scrutiny lately over safety concerns of approved drugs that were on the market but had to be recalled because of some serious adverse events reported by their customers. We can view mainly Merk’s Vioxx as the catalyst for this interest and examination [...]

Strengthening the FDA

Filed in Legal, November 6, 2007, 11:32 am by Mariano DiFabio

Two weeks ago, I wrote a post about a couple of major points in the history of the Food and Drug Administration (FDA) and how they redefined the responsibilities of the agency. These events set up the clinical trial process, and gave the FDA the authority to insist that consumable items be both safe and [...]

A Brief FDA History Lesson

Filed in Clinical Trials, General, Legal, Research, October 23, 2007, 11:29 pm by Mariano DiFabio

Just before a presentation I gave on Monday concerning Virtual Reality and its use in medicine, the group that had assembled was discussing a variety of current topics in the pharmaceutical and biotechnology industries. One of the attendees, Peter Castellano, caught my interest when he described an article he found in the October 2007 [...]

FDA Fast Track: Is Pay-for-review Too Fast?

Filed in Legal, Personal Health, Research, May 18, 2007, 2:22 pm by Mariano DiFabio

Following a topic I mentioned in the last post, I’d like to review the increasingly visible issue where approved drugs in the pharmaceutical market have come under greater scrutiny because of serious side effects of these medications. The trend seemed to start around the time Merck’s anti-inflammatory drug Vioxx was targeted because of its [...]