Category Archive
The following is a list of all entries from the Legal category.
Pharmaceutical start-ups: Phytomedics
Filed in Clinical Trials, Legal, Personal Health, Research, Safety, July 29, 2008, 12:01 am by Mariano DiFabioI read today about a really interesting pharmaceutical company that, though it’s considered a start-up, has spent the last 12 years researching and developing new drugs and methodologies that will allow for more rapid and safer development of drug products: Phytomedics. Their focus is on botanical drugs, which, in theory, could provide many of [...]
Ironing Out the Wrinkles
Filed in General, Legal, Personal Health, Research, February 8, 2008, 11:59 pm by Mariano DiFabioIt’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, [...]
FDA Balancing Act
Filed in Clinical Trials, Legal, November 16, 2007, 10:55 pm by Mariano DiFabioThe 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 [...]
Massachusetts could be Top on Biofuel Push
Filed in Legal, Technology, November 9, 2007, 10:50 pm by Mariano DiFabioNot that I’m an advocate of getting all my news from one source, but one of the news sites that I make regular visits to is the Boston.com web site. Originally from a suburb of Boston, I try to keep up with what’s going on in Beantown, I follow local sports teams, and find [...]
Strengthening the FDA
Filed in Legal, November 6, 2007, 11:32 am by Mariano DiFabioTwo 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 DiFabioJust 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 [...]
Ethical Dilemma
Filed in Clinical Trials, Legal, Personal Health, Research, September 11, 2007, 3:21 pm by Mariano DiFabioIn my second post ever on this site, I wrote about the FDA Fast Track program called Pay-For-Review, and I questioned whether drug companies who took advantage of this program were being given enough scrutiny for the products they were putting to market. Interestingly, in a Boston Globe article yesterday called “Burden of Proof,” [...]
Vioxx Litigation Update
Filed in Legal, September 7, 2007, 9:00 pm by Mariano DiFabioSome of my earliest posts for this blog explored the legal battles that face many pharmaceuticals today because of the proven dangers of their drugs that were not fully disclosed at the time the drugs were released into the market. I spoke of Vioxx, Zelnorm and Celebrex, though they were certainly not the only [...]
Death by Black Box
Filed in General, Legal, August 10, 2007, 12:01 am by Mariano DiFabioGlaxoSmithKline convinced an FDA panel on August 1st to keep its best selling diabetes drug, Avandia, on the market. If you weren’t aware, the drug was removed from the market recently because it was linked to cardiovascular disease in a small percentage of patients.Three cheers for Glaxo, right? Well, not quite. The [...]
FDA Fast Track: Is Pay-for-review Too Fast?
Filed in Legal, Personal Health, Research, May 18, 2007, 2:22 pm by Mariano DiFabioFollowing 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 [...]
