Author Archive
Obesity and Our Bacterial Friends
One of the persistent arguments in today’s world is whether obesity is in our genes or something that can be controlled by diet and exercise (and a good night’s sleep and low stress and …). On my way drive home from work last week, I heard a very interesting story on NPR about research on the [...]
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for a large pharmaceutical company (e.g. whether a product was submitted for approval, approved, actively marketed, withdrawn, etc.).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 [...]
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 [...]
Latest Tactics to Stifle Generic Competition
In the last half of this decade, it is estimated that $100 billion worth of brand name drugs have lost (or will lose) patent exclusivity. Each year, generic drugs take more and more of the market share from brand-name drug manufacturers. In fact, the percentage of drug prescriptions dispensed for generics increased from 47% to [...]
Bridion and the Tale of Two Agencies
Once upon a time, there was a promising new drug named Bridion. It was touted by its manufacturer as the first major pharmaceutical advance in the field of anesthesia in two decades. The drug was submitted to two powerful health authorities for marketing approval. Authorization looked like a foregone conclusion as advisory committees for both [...]
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