Monthly Archives: February 2006

What’s Inside That Black Box?

I have sat through an extraordinary number of FDA Advisory Committee meetings on a wide range of topics. During RX to OTC switch meetings, there is a great deal of fuss about the label and what it is going to … Continue reading

Posted in Risk Management | Comments Off on What’s Inside That Black Box?

Common Sense Confirmed

Common Sense Confirmed – Study Reveals Talking to the FDA is Good! – From the department of Dog Bites Man, the FDA issued a press release on February 9 revealing that pharmaceutical and biotech companies that communicate more frequently and earlier … Continue reading

Posted in Regulatory Communications | Comments Off on Common Sense Confirmed

The Value of Drugs and the Standing of Industry

The Value of Drugs and the Standing of Industry – It is Friday, so this is going to be one of those occasions where I am going to claim artistic license and not focus specifically on a matter related FDA … Continue reading

Posted in Pharma Industry Image | Comments Off on The Value of Drugs and the Standing of Industry

Considerations for a New Regulatory Environment

February 15, 2006 – This is a time for a lot of soul searching on the part of industry as well as the FDA. Events of the past two years are shaping an entirely new landscape in drug development and … Continue reading

Posted in Safety and Clinical Trials | Comments Off on Considerations for a New Regulatory Environment

Welcome to my Blog. I am happy to be here with you.

Who am I?  My name is Mark Senak.  I’m a lawyer and I work at the international communications firm Fleishman-Hillard in Washington D.C.  For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged … Continue reading

Posted in About Me | Comments Off on Welcome to my Blog. I am happy to be here with you.