About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. 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.
My ProfileI am an 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; and counselor in issues and crisis management. I am a 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 BlogEye 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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Category Archives: Risk Management
Everyone has heard of the concept of personalized medicine – the idea that medicine can be steered to individuals who will be the most likely to benefit from it based on a number of factors, primarily genetic. Personalized medicine involves … Continue reading
MedGuides are pieces of paper that are shoved into a bag with your prescription to warn a patient about possible side effects. I take some prescriptions myself that come with MedGuides. I never have read one all the way through, … Continue reading
No, it isn't a scientific breakthrough – it is a regulatory breakthrough. Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who experience breakthrough pain who have developed a level … Continue reading
Obama Administration Shifts Agency Gears on Safety – What Does it Mean for Food and What Does it Mean for Drugs
There have been a lot of changes at the FDA in the past few weeks – changes in personnel and changes in approach. Today the New York Times reports that Dr. Joshua Sharfstein, who has taken the reigns as Acting … Continue reading
Yesterday, the FDA announced that it has sent letters to the manufacturers of both generic and brand name opioid based products that they may be required to have a Risk Evaluation Mitigation Strategy (REMS), which the agency now has the … Continue reading