Tag Archives: OPDP

An Overview of FDA OPDP Enforcement for 2019

Posted on January 16, 2020 by Mark Senak

It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between the time a letter is sent and the time it is … Continue reading →

Posted in Warning Letters | Tagged FDA Enforcement, OPDP, Warning Letters | Comments Off

Enforcement Updates: OPDP Issues First Letter of the Year

Posted on March 13, 2019 by Mark Senak

In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been diminished in the volume of its enforcement expressed through the issuance of Warning and Untitled Letters. OPDP now sends out only a handful of letters each year when … Continue reading →

Posted in Warning Letters | Tagged FDA, OPDP, Pharma | 2 Comments

About the Author
My 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.
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I 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!
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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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Tag Archives: OPDP

An Overview of FDA OPDP Enforcement for 2019

Enforcement Updates: OPDP Issues First Letter of the Year

About the Author

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About This Blog

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