Archive for October, 2008
Checking in on the Status of Electronic Application Submissions
A few years ago, I was the project manager for a system that tracked the status of drug products worldwide for a large pharmaceutical company (e.g. whether a product was submitted for approval, approved, actively marketed, withdrawn, etc.). Back then, health authorities, such as the FDA in the US and the EMEA in the European [...]
Brain Drain, Smoking, and Jenny McCarthy
The past few weeks have been rough. I have a lot of project work going on, and I find myself staying up later and later to try to keep up with it all. I guess it’s one of the consequences of trying to build a new company, grow a family, and keep in shape. There [...]
Compassionate Use for Investigational Drugs
In the Avelient BioPharm Blog article “A Brief FDA History Lesson“, Mariano Di Fabio provided some background on the events that lead to the establishment of the FDA’s current clinical trial framework, and he questioned if this framework should be changed so that experimental drugs could be released for use by terminally ill patients. Mariano [...]
Loosing Sleep over Economic Crisis
It seems almost every conversation these days starts with people lamenting over the state of their stock portfolios. No matter what you’ve invested in, no matter how secure you believe your investments to be, you get weak in the knees when going to check on the current state of your 401k, or 503b, or 529 [...]
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