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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Tag Archives: #OPDP
It Finally Happened – FDA’s OPDP Issues First Letter of 2023
For those who are regular followers of what FDA’s Office of Prescription Drug Promotion (OPDP) is up to, there was a surprise this week when the office posted the first regulatory action letter – in this case an Untitled Letter … Continue reading
Posted in Warning Letters
Tagged #DTC, #OPDP, #pharma, #Warning Letter
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FDA Announces New Study on Endorsements and DTC Television Ads
In today’s Federal Register, the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range … Continue reading
Posted in DTC Advertising, FDA Policy
Tagged #DTC, #OPDP, #pharma
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OPDP Outlines New Research
FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same … Continue reading
Posted in FDA Policy, Research
Tagged #DTC, #OPDP, #pharma
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Speaking of Medicine – Mid-Year OPDP Enforcement Review
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement … Continue reading
Posted in Uncategorized
Tagged #OPDP, #pharma
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Enforcement Update: OPDP Issues Untitled Letter
We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, … Continue reading
Posted in Warning Letters
Tagged #OPDP
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