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: OTC Switches
Remember when your phone was just a phone? You flipped it open and made a call. It also may have told you the time, but you primarily used it for talking to people. Today you actually use it in ways … Continue reading
As many long time readers know from earlier postings about this topic, when I step on my bathroom scale, it records my weight and sends it to my iPad. I have a blood pressure cuff that hooks up that very … Continue reading
Once upon a time, it was quite common for drugs to switch their status from prescription to over-the-counter (OTC) making them much more accessible to people by means of ability to purchase and cost. Allergy medications and heartburn treatments saw … Continue reading
In the 1990s the number of drugs that switched from Rx status to Over-the-Counter (OTC) was quite high and the Non-prescription Drugs Advisory Committee (NDAC) was having a lot of meetings to consider switches of several heartburn remedies, allergy medications … Continue reading