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: FDA Enforcement
An Overview of FDA OPDP Enforcement for 2019
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
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2020 Vision – Notable FDA Actions During 2019
Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a … Continue reading
Posted in FDA Image, FDA Policy
Tagged FDA 2019, FDA Approvals, FDA CBD, FDA Enforcement
Comments Off on 2020 Vision – Notable FDA Actions During 2019