Monthly Archives: July 2017

FDA and Patient Involvement

Posted on July 27, 2017 by Mark Senak

“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading →

Posted in Clinical Trials, FDA Image, FDA Policy | Comments Off

What They Said – 2nd Quarter 2017

Posted on July 6, 2017 by Mark Senak

During a somewhat slow week given the holiday that coincides with the end of the second quarter, this is a good time to look back at press releases for the quarter and the year so far. A single press release … Continue reading →

Posted in FDA Image | Comments Off

About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market.
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EXPERTISE - Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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July 2017

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The U.S. Pharmacopeia – What is it? What Does it Do?

I had the pleasure of chatting with Dr. Roger L. Williams, CEO of the USP to talk about what the campaign is designed to accomplish and what it is that the USP actually does. There are two installments of podcasting here - the first which talks about what the USP does, and the second geared to the campaign itself.
FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua Sharfstein

I had the opportunity last Friday to sit down with Dr. Joshua Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration to discuss FDA Track. We talked about the genesis of the program, how they are doing it, what those of us in the public who are interested can expect of the program, and the process and timeframe for bringing it entirely up and running. Check it out.
Legislative Tracking Tools

Monthly Archives: July 2017

FDA and Patient Involvement

What They Said – 2nd Quarter 2017

About the Author

Stay Connected

My Profile

About This Blog

Posts by Date

My Favorite Dogs

Twitter List

The U.S. Pharmacopeia – What is it? What Does it Do?

FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua Sharfstein

Legislative Tracking Tools

RSS

My Employer

Books by Me

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